S0816 Fludeoxyglucose F 18-PET/CT Imaging and Combination Chemotherapy With or Without Additional Chemotherapy and G-CSF in Treating Patients With Stage III or Stage IV Hodgkin Lymphoma

August 16, 2022 updated by: Southwest Oncology Group

A Phase II Trial of Response-Adapted Therapy of Stage III-IV Hodgkin Lymphoma Using Early Interim FDG-PET Imaging

RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells. G-CSF may help lessen the side effects in patients receiving chemotherapy. Imaging procedures, such as fludeoxyglucose F 18-PET/CT imaging, may help doctors predict how patients will respond to treatment.

PURPOSE: This phase II trial is studying fludeoxyglucose F 18-PET/CT imaging to see how well it works in assessing response to combination chemotherapy and allow doctors to plan better additional further treatment in treating patients with stage III or stage IV Hodgkin lymphoma.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

Primary

To estimate the 2-year progression-free survival (PFS) of HIV-negative patients with stage III-IV Hodgkin lymphoma treated with response-adapted therapy based on fludeoxyglucose F 18 (FDG)-PET imaging after 2 courses of doxorubicin hydrochloride, bleomycin, vinblastine, and dacarbazine (ABVD).
To estimate the 2-year PFS of patients who are PET-positive after treatment with 2 courses of ABVD and an escalated dose regimen comprising cyclophosphamide, doxorubicin hydrochloride, etoposide, vincristine sulfate, bleomycin, procarbazine hydrochloride, and prednisone (BEACOPP).

Secondary

To estimate the 2-year overall survival (OS) of patients treated with these regimens.
To estimate the response rate (i.e., complete and partial responses) in patients treated with these regimens.
To evaluate the toxicity of these response-adapted regimens.
To document the feasibility of centralized, real-time review of FDG-PET imaging for U.S. cooperative group studies.
To prospectively evaluate the overall response rate, complete response rate, PFS, and OS of HIV-positive patients treated with these response-adapted regimens.

OUTLINE: This is a multicenter study.

All patients undergo baseline whole-body fludeoxyglucose F 18 (FDG)-PET/CT imaging before beginning chemotherapy. Patients then receive doxorubicin hydrochloride IV, bleomycin IV, vinblastine IV, and dacarbazine IV (ABVD) on days 1 and 15. Treatment repeats every 28 days for up to 2 courses in the absence of disease progression or unacceptable toxicity. Between days 22 and 25 of course 2, patients undergo a second FDG-PET/CT scan to assess response. Subsequent therapy is based on FDG-PET/CT scan results. Patients are stratified according to FDG-PET positivity (yes vs no). Patients who are FDG-PET-negative continue treatment with ABVD for up to 4 additional courses in the absence of disease progression or unacceptable toxicity. Patients who are FDG-PET-positive are then further stratified according to HIV positivity (yes or no) and receive 1 of the following treatment regimens:

Escalated-dose BEACOPP chemotherapy: HIV-negative patients receive escalated-dose BEACOPP chemotherapy comprising doxorubicin hydrochloride IV and cyclophosphamide IV on day 1, etoposide IV on days 1-3, oral procarbazine hydrochloride on days 1-7, oral prednisone on days 1-14, and bleomycin IV and vincristine IV on day 8. Patients receive filgrastim (G-CSF) subcutaneously on days 8-14. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Standard-dose BEACOPP chemotherapy: HIV-positive patients receive standard dose BEACOPP chemotherapy comprising doxorubicin hydrochloride IV and cyclophosphamide IV on day 1, etoposide IV on days 1-3, oral procarbazine hydrochloride on days 1-7, oral prednisone on days 1-14, and bleomycin IV and vincristine IV on day 8. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.

Six to eight weeks after completion of chemotherapy, patients undergo a post-treatment FDG-PET/CT scan.

Some patients may undergo bone marrow biopsy at 1 month after the last course of chemotherapy.

After completion of study treatment, patients are followed up periodically for 7 years.

Study Type

Interventional

Enrollment (Actual)

371

Phase

Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- Arizona
  - Tucson, Arizona, United States, 85719
    - Arizona Cancer Center at University Medical Center North
  - Tucson, Arizona, United States, 85724-5024
    - Arizona Cancer Center at University of Arizona Health Sciences Center
- Arkansas
  - Little Rock, Arkansas, United States, 72205
    - Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
  - Rogers, Arkansas, United States, 72758
    - Highlands Oncology Group - Springdale
- California
  - Anaheim, California, United States, 92807
    - Kaiser Permanente Medical Center - Anaheim/Orange County
  - Antioch, California, United States, 94531
    - Kaiser Permanente - Deer Valley
  - Baldwin Park, California, United States, 91706
    - Kaiser Permanente Medical Center - Baldwin Park
  - Bellflower, California, United States, 90706
    - Kaiser Permanente Medical Center - Bellflower
  - Duarte, California, United States, 91010-3000
    - City of Hope Comprehensive Cancer Center
  - Fontana, California, United States, 92335
    - Kaiser Permanente Medical Center - Fontana
  - Fremont, California, United States, 94538
    - Kaiser Permanente - Fremont
  - Fresno, California, United States, 93720
    - Kaiser Permanente Fresno Medical Center
  - Harbor City, California, United States, 90710
    - Kaiser Permanente Medical Center - Harbor City
  - Hayward, California, United States, 94545
    - Kaiser Permanente Medical Center - Hayward
  - Irvine, California, United States, 92618
    - Kaiser Permanente - Irvine
  - La Jolla, California, United States, 92093-0658
    - Rebecca and John Moores UCSD Cancer Center
  - Los Angeles, California, United States, 90027
    - Kaiser Permanente Medical Center - Los Angeles
  - Los Angeles, California, United States, 90034
    - Kaiser Foundation Hospital - West Los Angeles
  - Oakland, California, United States, 94611
    - Kaiser Permanente Medical Center - Oakland
  - Panorama City, California, United States, 91402
    - Kaiser Permanente Medical Group
  - Redwood City, California, United States, 94063
    - Kaiser Permanente Medical Center - Redwood City
  - Richmond, California, United States, 94801
    - Kaiser Permanente Medical Center - Richmond
  - Riverside, California, United States, 92505
    - Kaiser Permanente Medical Center - Riverside
  - Roseville, California, United States, 95661
    - Kaiser Permanente Medical Center - Roseville
  - Sacramento, California, United States, 95817
    - University of California Davis Cancer Center
  - Sacramento, California, United States, 95823
    - South Sacramento Kaiser-Permanente Medical Center
  - Sacramento, California, United States, 95825
    - Kaiser Permanente Medical Center - Sacramento
  - San Diego, California, United States, 92120
    - Kaiser Permanente Medical Center - Kaiser Foundation Hospital - San Diego
  - San Francisco, California, United States, 94115
    - UCSF Helen Diller Family Comprehensive Cancer Center
  - San Francisco, California, United States, 94115
    - Kaiser Permanente Medical Center - San Francisco Geary Campus
  - San Jose, California, United States, 95119
    - Kaiser Permanente Medical Center - Santa Teresa
  - San Marcos, California, United States, 92078
    - Kaiser Permanente Health Care
  - San Rafael, California, United States, 94903
    - Kaiser Foundation Hospital - San Rafael
  - Santa Clara, California, United States, 95051
    - Kaiser Permanente Medical Center - Santa Clara Kiely Campus
  - Santa Rosa, California, United States, 95403
    - Kaiser Permanente Medical Center - Santa Rosa
  - South San Francisco, California, United States, 94080
    - Kaiser Permanente Medical Center - South San Francisco
  - Stanford, California, United States, 94305-5824
    - Stanford Cancer Center
  - Stockton, California, United States, 95210
    - Kaiser Permanente Medical Facility - Stockton
  - Vacaville, California, United States, 95688
    - Kaiser Permanente Medical Center - Vacaville
  - Vallejo, California, United States, 94589
    - Kaiser Permanente Medical Center - Vallejo
  - Walnut Creek, California, United States, 94596
    - Kaiser Permanente Medical Center - Walnut Creek
  - Woodland Hills, California, United States, 91367
    - Kaiser Permanente Medical Cener - Woodland Hills
- Colorado
  - Aurora, Colorado, United States, 80012
    - Aurora Presbyterian Hospital
  - Boulder, Colorado, United States, 80301-9019
    - Boulder Community Hospital
  - Colorado Springs, Colorado, United States, 80933
    - Penrose Cancer Center at Penrose Hospital
  - Denver, Colorado, United States, 80210
    - Porter Adventist Hospital
  - Denver, Colorado, United States, 80220
    - Rose Medical Center
  - Denver, Colorado, United States, 80218
    - Presbyterian - St. Luke's Medical Center
  - Denver, Colorado, United States, 80204
    - St. Anthony Central Hospital
  - Denver, Colorado, United States, 80218
    - St. Joseph Hospital
  - Denver, Colorado, United States, 80222
    - CCOP - Colorado Cancer Research Program
  - Denver, Colorado, United States, 80205
    - Kaiser Permanente - Denver
  - Englewood, Colorado, United States, 80110
    - Swedish Medical Center
  - Fort Collins, Colorado, United States, 80524
    - Poudre Valley Hospital
  - Fort Collins, Colorado, United States, 80528
    - Front Range Cancer Specialists
  - Grand Junction, Colorado, United States, 81502
    - St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center
  - Greeley, Colorado, United States, 80631
    - North Colorado Medical Center
  - Lafayette, Colorado, United States, 80026
    - Kaiser Permanente - Lafayette
  - Littleton, Colorado, United States, 80122
    - Littleton Adventist Hospital
  - Lone Tree, Colorado, United States, 80124
    - Sky Ridge Medical Center
  - Longmont, Colorado, United States, 80501
    - Hope Cancer Care Center at Longmont United Hospital
  - Loveland, Colorado, United States, 80539
    - McKee Medical Center
  - Parker, Colorado, United States, 80138
    - Parker Adventist Hospital
  - Pueblo, Colorado, United States, 81004
    - St. Mary - Corwin Regional Medical Center
  - Thornton, Colorado, United States, 80229
    - North Suburban Medical Center
  - Wheat Ridge, Colorado, United States, 80033
    - Exempla Lutheran Medical Center
- Connecticut
  - Hartford, Connecticut, United States, 06105
    - Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center
  - Manchester, Connecticut, United States, 06040
    - Manchester Memorial Hospital
  - New Haven, Connecticut, United States, 06520-8028
    - Yale Cancer Center
- Delaware
  - Lewes, Delaware, United States, 19958
    - Tunnell Cancer Center at Beebe Medical Center
  - Newark, Delaware, United States, 19713
    - CCOP - Christiana Care Health Services
- District of Columbia
  - Washington, District of Columbia, United States, 20007
    - Lombardi Comprehensive Cancer Center at Georgetown University Medical Center
- Florida
  - Orlando, Florida, United States, 32806
    - M.D. Anderson Cancer Center at Orlando
- Georgia
  - Athens, Georgia, United States, 30607
    - Northeast Georgia Cancer Care, LLC - Medical Oncology
  - Atlanta, Georgia, United States, 30322
    - Winship Cancer Institute of Emory University
  - Augusta, Georgia, United States, 30912
    - MBCCOP - Medical College of Georgia Cancer Center
- Hawaii
  - 'Aiea, Hawaii, United States, 96701
    - Kapiolani Medical Center at Pali Momi
  - Honolulu, Hawaii, United States, 96813
    - Cancer Research Center of Hawaii
  - Honolulu, Hawaii, United States, 96826
    - Kapiolani Medical Center for Women and Children
  - Honolulu, Hawaii, United States, 96813
    - OnCare Hawaii, Incorporated - Lusitana
  - Honolulu, Hawaii, United States, 96813
    - Queen's Cancer Institute at Queen's Medical Center
  - Honolulu, Hawaii, United States, 96813
    - Straub Clinic and Hospital, Incorporated
  - Honolulu, Hawaii, United States, 96817
    - Hawaii Medical Center - East
  - Honolulu, Hawaii, United States, 96817
    - OnCare Hawaii, Incorporated - Kuakini
  - Honolulu, Hawaii, United States, 96859
    - Tripler Army Medical Center
  - Honolulu, Hawaii, United States, 96819
    - Kaiser Permanente - Moanalua Medical Center and Clinic
  - Kailua, Hawaii, United States, 96734
    - Castle Medical Center
  - Lihue, Hawaii, United States, 96766
    - Kauai Medical Clinic
  - Wailuku, Hawaii, United States, 96793
    - Maui Memorial Medical Center
  - Wailuku, Hawaii, United States, 96793
    - Pacific Cancer Institute - Maui
- Idaho
  - Boise, Idaho, United States, 83706
    - Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center
  - Lewiston, Idaho, United States, 83501
    - St. Joseph Regional Medical Center
  - Meridian, Idaho, United States, 83642
    - Idaho Urologic Institute, PA
- Illinois
  - Bloomington, Illinois, United States, 61701
    - Illinois CancerCare - Bloomington
  - Bloomington, Illinois, United States, 61701
    - St. Joseph Medical Center
  - Canton, Illinois, United States, 61520
    - Illinois CancerCare - Canton
  - Canton, Illinois, United States, 61520
    - Graham Hospital
  - Carthage, Illinois, United States, 62321
    - Memorial Hospital
  - Carthage, Illinois, United States, 62321
    - Illinois CancerCare - Carthage
  - Chicago, Illinois, United States, 60637-1470
    - University of Chicago Cancer Research Center
  - Chicago, Illinois, United States, 60612-3785
    - John H. Stroger, Jr. Hospital of Cook County
  - Decatur, Illinois, United States, 62526
    - Decatur Memorial Hospital Cancer Care Institute
  - Elgin, Illinois, United States, 60123
    - Sherman Hospital
  - Eureka, Illinois, United States, 61530
    - Illinois CancerCare - Eureka
  - Eureka, Illinois, United States, 61530
    - Eureka Community Hospital
  - Galesburg, Illinois, United States, 61401
    - Illinois CancerCare - Galesburg
  - Galesburg, Illinois, United States, 61401
    - Galesburg Clinic, PC
  - Geneva, Illinois, United States, 60134
    - Delnor Hospital - Geneva
  - Havana, Illinois, United States, 62644
    - Illinois CancerCare - Havana
  - Kewanee, Illinois, United States, 61443
    - Illinois CancerCare - Kewanee Clinic
  - Macomb, Illinois, United States, 61455
    - Illinois CancerCare - Macomb
  - Macomb, Illinois, United States, 61455
    - Mcdonough District Hospital
  - Maywood, Illinois, United States, 60153
    - Cardinal Bernardin Cancer Center at Loyola University Medical Center
  - Monmouth, Illinois, United States, 61462
    - Illinois CancerCare - Monmouth
  - Monmouth, Illinois, United States, 61462
    - OSF Holy Family Medical Center
  - Normal, Illinois, United States, 61761
    - Bromenn Regional Medical Center
  - Normal, Illinois, United States, 61761
    - Community Cancer Center
  - Normal, Illinois, United States, 61761
    - Illinois CancerCare - Community Cancer Center
  - Ottawa, Illinois, United States, 61350
    - Community Hospital of Ottawa
  - Ottawa, Illinois, United States, 61350
    - Oncology Hematology Associates of Central Illinois, PC - Ottawa
  - Pekin, Illinois, United States, 61554
    - Cancer Treatment Center at Pekin Hospital
  - Pekin, Illinois, United States, 61603
    - Illinois CancerCare - Pekin
  - Peoria, Illinois, United States, 61636
    - Methodist Medical Center of Illinois
  - Peoria, Illinois, United States, 61614
    - Proctor Hospital
  - Peoria, Illinois, United States, 61637
    - OSF St. Francis Medical Center
  - Peoria, Illinois, United States, 61615
    - CCOP - Illinois Oncology Research Association
  - Peoria, Illinois, United States, 61615
    - Oncology Hematology Associates of Central Illinois, PC - Peoria
  - Peru, Illinois, United States, 61354
    - Illinois CancerCare - Peru
  - Peru, Illinois, United States, 61354
    - Illinois Valley Community Hospital
  - Princeton, Illinois, United States, 61356
    - Perry Memorial Hospital
  - Princeton, Illinois, United States, 61356
    - Illinois CancerCare - Princeton
  - Spring Valley, Illinois, United States, 61362
    - Illinois CancerCare - Spring Valley
  - Springfield, Illinois, United States, 62781-0001
    - Regional Cancer Center at Memorial Medical Center
  - Warrenville, Illinois, United States, 60555
    - Central Dupage Cancer Center
- Indiana
  - Beech Grove, Indiana, United States, 46107
    - St. Francis Hospital and Health Centers - Beech Grove Campus
  - Fort Wayne, Indiana, United States, 46845
    - Fort Wayne Medical Oncology and Hematology
  - Richmond, Indiana, United States, 47374
    - Reid Hospital & Health Care Services
- Iowa
  - Sioux City, Iowa, United States, 51101
    - Siouxland Hematology-Oncology Associates, LLP
  - Sioux City, Iowa, United States, 51102
    - Mercy Medical Center - Sioux City
  - Sioux City, Iowa, United States, 51104
    - St. Luke's Regional Medical Center
- Kansas
  - Chanute, Kansas, United States, 66720
    - Cancer Center of Kansas, PA - Chanute
  - Dodge City, Kansas, United States, 67801
    - Cancer Center of Kansas, PA - Dodge City
  - El Dorado, Kansas, United States, 67042
    - Cancer Center of Kansas, PA - El Dorado
  - Fort Scott, Kansas, United States, 66701
    - Cancer Center of Kansas - Fort Scott
  - Independence, Kansas, United States, 67301
    - Cancer Center of Kansas-Independence
  - Kansas City, Kansas, United States, 66112
    - Providence Medical Center
  - Kingman, Kansas, United States, 67068
    - Cancer Center of Kansas, PA - Kingman
  - Lawrence, Kansas, United States, 66044
    - Lawrence Memorial Hospital
  - Liberal, Kansas, United States, 67901
    - Cancer Center of Kansas, PA - Liberal
  - McPherson, Kansas, United States, 67460
    - Cancer Center of Kansas, PA - McPherson
  - Newton, Kansas, United States, 67114
    - Cancer Center of Kansas, PA - Newton
  - Overland Park, Kansas, United States, 66209
    - Menorah Medical Center
  - Overland Park, Kansas, United States, 66213
    - Saint Luke's Hospital - South
  - Parsons, Kansas, United States, 67357
    - Cancer Center of Kansas, PA - Parsons
  - Prairie Village, Kansas, United States, 66208
    - CCOP - Kansas City
  - Pratt, Kansas, United States, 67124
    - Cancer Center of Kansas, PA - Pratt
  - Salina, Kansas, United States, 67401
    - Cancer Center of Kansas, PA - Salina
  - Salina, Kansas, United States, 67401
    - Tammy Walker Cancer Center at Salina Regional Health Center
  - Topeka, Kansas, United States, 66606
    - Cotton-O'Neil Cancer Center
  - Wellington, Kansas, United States, 67152
    - Cancer Center of Kansas, PA - Wellington
  - Wichita, Kansas, United States, 67208
    - Cancer Center of Kansas, PA - Medical Arts Tower
  - Wichita, Kansas, United States, 67214
    - Cancer Center of Kansas, PA - Wichita
  - Wichita, Kansas, United States, 67214
    - CCOP - Wichita
  - Wichita, Kansas, United States, 67214
    - Via Christi Cancer Center at Via Christi Regional Medical Center
  - Wichita, Kansas, United States, 67208
    - Associates in Womens Health, PA - North Review
  - Winfield, Kansas, United States, 67156
    - Cancer Center of Kansas, PA - Winfield
- Kentucky
  - Lexington, Kentucky, United States, 40536-0093
    - Lucille P. Markey Cancer Center at University of Kentucky
  - Louisville, Kentucky, United States, 40202
    - Louisville Oncology at Norton Cancer Institute - Louisville
- Louisiana
  - Baton Rouge, Louisiana, United States, 70809
    - Mary Bird Perkins Cancer Center - Baton Rouge
  - Baton Rouge, Louisiana, United States, 70809
    - Ochsner Health Center - Bluebonnet
  - Covington, Louisiana, United States, 70433
    - Ochsner Health Center - Covington
  - New Orleans, Louisiana, United States, 70121
    - CCOP - Ochsner
  - New Orleans, Louisiana, United States, 70112
    - MBCCOP - LSU Health Sciences Center
  - New Orleans, Louisiana, United States, 70121
    - Ochsner Cancer Institute at Ochsner Clinic Foundation
  - New Orleans, Louisiana, United States, 70112
    - Medical Center of Louisiana - New Orleans
  - Shreveport, Louisiana, United States, 71130-3932
    - Feist-Weiller Cancer Center at Louisiana State University Health Sciences
- Maryland
  - Baltimore, Maryland, United States, 21231-2410
    - Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
  - Baltimore, Maryland, United States, 21215
    - Alvin and Lois Lapidus Cancer Institute at Sinai Hospital
  - Baltimore, Maryland, United States, 21201
    - Greenebaum Cancer Center at University of Maryland Medical Center
  - Baltimore, Maryland, United States, 21204
    - Greater Baltimore Medical Center Cancer Center
  - Bethesda, Maryland, United States, 20889-5600
    - National Naval Medical Center
  - Elkton, Maryland, United States, 21921
    - Union Hospital of Cecil County
- Massachusetts
  - Boston, Massachusetts, United States, 02215
    - Beth Israel Deaconess Medical Center
  - Boston, Massachusetts, United States, 02118
    - Boston University Cancer Research Center
  - Boston, Massachusetts, United States, 02115
    - Dana-Farber/Brigham and Women's Cancer Center
  - Boston, Massachusetts, United States, 02115
    - Dana-Farber/Harvard Cancer Center at Dana-Farber Cancer Institute
  - Gloucester, Massachusetts, United States, 01930
    - Addison Gilbert Hospital
  - Worcester, Massachusetts, United States, 01655
    - UMASS Memorial Cancer Center - University Campus
- Michigan
  - Adrian, Michigan, United States, 49221
    - Hickman Cancer Center at Bixby Medical Center
  - Ann Arbor, Michigan, United States, 48109-0942
    - University of Michigan Comprehensive Cancer Center
  - Ann Arbor, Michigan, United States, 48106-0995
    - Saint Joseph Mercy Cancer Center
  - Ann Arbor, Michigan, United States, 48106
    - CCOP - Michigan Cancer Research Consortium
  - Battle Creek, Michigan, United States, 49017
    - Battle Creek Health System Cancer Care Center
  - Big Rapids, Michigan, United States, 49307
    - Mecosta County Medical Center
  - Dearborn, Michigan, United States, 48123-2500
    - Oakwood Cancer Center at Oakwood Hospital and Medical Center
  - Detroit, Michigan, United States, 48202
    - Josephine Ford Cancer Center at Henry Ford Hospital
  - Detroit, Michigan, United States, 48201-1379
    - Barbara Ann Karmanos Cancer Institute
  - Escanaba, Michigan, United States, 49431
    - Green Bay Oncology, Limited - Escanaba
  - Flint, Michigan, United States, 48503
    - Hurley Medical Center
  - Flint, Michigan, United States, 48503
    - Genesys Hurley Cancer Institute
  - Grand Blanc, Michigan, United States, 48439
    - Genesys Regional Medical Center
  - Grand Rapids, Michigan, United States, 49503
    - Butterworth Hospital at Spectrum Health
  - Grand Rapids, Michigan, United States, 49503
    - CCOP - Grand Rapids
  - Grand Rapids, Michigan, United States, 49503
    - Lacks Cancer Center at Saint Mary's Health Care
  - Grosse Pointe Woods, Michigan, United States, 48236
    - Van Elslander Cancer Center at St. John Hospital and Medical Center
  - Iron Mountain, Michigan, United States, 49801
    - Dickinson County Healthcare System
  - Jackson, Michigan, United States, 49201
    - Foote Memorial Hospital
  - Kalamazoo, Michigan, United States, 49007
    - Bronson Methodist Hospital
  - Kalamazoo, Michigan, United States, 49001
    - Borgess Medical Center
  - Kalamazoo, Michigan, United States, 49007-3731
    - West Michigan Cancer Center
  - Lansing, Michigan, United States, 48912-1811
    - Sparrow Regional Cancer Center
  - Livonia, Michigan, United States, 48154
    - St. Mary Mercy Hospital
  - Monroe, Michigan, United States, 48162
    - Community Cancer Center of Monroe
  - Monroe, Michigan, United States, 48162
    - Mercy Memorial Hospital - Monroe
  - Muskegon, Michigan, United States, 49444
    - Mercy General Health Partners
  - Pontiac, Michigan, United States, 48341-2985
    - St. Joseph Mercy Oakland
  - Port Huron, Michigan, United States, 48060
    - Mercy Regional Cancer Center at Mercy Hospital
  - Reed City, Michigan, United States, 49677
    - Spectrum Health Reed City Hospital
  - Saginaw, Michigan, United States, 48601
    - Seton Cancer Institute at Saint Mary's - Saginaw
  - Traverse City, Michigan, United States, 49684
    - Munson Medical Center
  - Warren, Michigan, United States, 48093
    - St. John Macomb Hospital
- Minnesota
  - Burnsville, Minnesota, United States, 55337
    - Fairview Ridges Hospital
  - Coon Rapids, Minnesota, United States, 55433
    - Mercy and Unity Cancer Center at Mercy Hospital
  - Duluth, Minnesota, United States, 55805
    - CCOP - Duluth
  - Duluth, Minnesota, United States, 55805-1983
    - Duluth Clinic Cancer Center - Duluth
  - Duluth, Minnesota, United States, 55805
    - Miller - Dwan Medical Center
  - Edina, Minnesota, United States, 55435
    - Fairview Southdale Hospital
  - Fridley, Minnesota, United States, 55432
    - Mercy and Unity Cancer Center at Unity Hospital
  - Hutchinson, Minnesota, United States, 55350
    - Hutchinson Area Health Care
  - Maplewood, Minnesota, United States, 55109
    - HealthEast Cancer Care at St. John's Hospital
  - Maplewood, Minnesota, United States, 55109
    - Minnesota Oncology - Maplewood
  - Minneapolis, Minnesota, United States, 55407
    - Virginia Piper Cancer Institute at Abbott - Northwestern Hospital
  - Minneapolis, Minnesota, United States, 55415
    - Hennepin County Medical Center - Minneapolis
  - New Ulm, Minnesota, United States, 56073
    - New Ulm Medical Center
  - Robbinsdale, Minnesota, United States, 55422-2900
    - Humphrey Cancer Center at North Memorial Outpatient Center
  - Saint Louis Park, Minnesota, United States, 55416
    - CCOP - Metro-Minnesota
  - Saint Louis Park, Minnesota, United States, 55416
    - Park Nicollet Cancer Center
  - Saint Paul, Minnesota, United States, 55102
    - United Hospital
  - Saint Paul, Minnesota, United States, 55101
    - Regions Hospital Cancer Care Center
  - Shakopee, Minnesota, United States, 55379
    - St. Francis Cancer Center at St. Francis Medical Center
  - Stillwater, Minnesota, United States, 55082
    - Lakeview Hospital
  - Waconia, Minnesota, United States, 55387
    - Ridgeview Medical Center
  - Willmar, Minnesota, United States, 56201
    - Willmar Cancer Center at Rice Memorial Hospital
  - Woodbury, Minnesota, United States, 55125
    - Minnesota Oncology - Woodbury
- Missouri
  - Kansas City, Missouri, United States, 64116
    - North Kansas City Hospital
  - Kansas City, Missouri, United States, 64132
    - Research Medical Center
  - Kansas City, Missouri, United States, 64111
    - Saint Luke's Cancer Institute at Saint Luke's Hospital
  - Kansas City, Missouri, United States, 64118
    - Heartland Hematology Oncology Associates, Incorporated
  - Lee's Summit, Missouri, United States, 64086
    - Saint Luke's East - Lee's Summit
  - Liberty, Missouri, United States, 64068
    - Parvin Radiation Oncology
  - Saint Joseph, Missouri, United States, 64506
    - Heartland Regional Medical Center
  - Saint Joseph, Missouri, United States, 64507
    - Saint Joseph Oncology, Incorporated
  - Saint Louis, Missouri, United States, 63110
    - Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
  - Springfield, Missouri, United States, 65802
    - CCOP - Cancer Research for the Ozarks
  - Springfield, Missouri, United States, 65804
    - St. John's Regional Health Center
  - Springfield, Missouri, United States, 65807
    - Hulston Cancer Center at Cox Medical Center South
- Montana
  - Billings, Montana, United States, 59101
    - CCOP - Montana Cancer Consortium
  - Billings, Montana, United States, 59101
    - St. Vincent Healthcare Cancer Care Services
  - Billings, Montana, United States, 59107-7000
    - Billings Clinic - Downtown
  - Billings, Montana, United States, 59102
    - Hematology-Oncology Centers of the Northern Rockies - Billings
  - Bozeman, Montana, United States, 59715
    - Bozeman Deaconess Cancer Center
  - Butte, Montana, United States, 59701
    - St. James Healthcare Cancer Care
  - Great Falls, Montana, United States, 59405
    - Great Falls Clinic - Main Facility
  - Great Falls, Montana, United States, 59405
    - Sletten Cancer Institute at Benefis Healthcare
  - Helena, Montana, United States, 59601
    - St. Peter's Hospital
  - Kalispell, Montana, United States, 59901
    - Kalispell Regional Medical Center
  - Kalispell, Montana, United States, 59901
    - Glacier Oncology, PLLC
  - Kalispell, Montana, United States, 59901
    - Kalispell Medical Oncology at KRMC
  - Missoula, Montana, United States, 59807-7877
    - Montana Cancer Specialists at Montana Cancer Center
  - Missoula, Montana, United States, 59807
    - Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
- Nebraska
  - Omaha, Nebraska, United States, 68198-6805
    - UNMC Eppley Cancer Center at the University of Nebraska Medical Center
- Nevada
  - Las Vegas, Nevada, United States, 89102
    - University Medical Center of Southern Nevada
  - Las Vegas, Nevada, United States, 89106
    - CCOP - Nevada Cancer Research Foundation
- New Hampshire
  - Lebanon, New Hampshire, United States, 03756-0002
    - Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
- New Jersey
  - Hamilton, New Jersey, United States, 08690
    - Cancer Institute of New Jersey at Hamilton
  - New Brunswick, New Jersey, United States, 08903
    - Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
  - Voorhees, New Jersey, United States, 08043
    - Cancer Institute of New Jersey at Cooper - Voorhees
- New Mexico
  - Albuquerque, New Mexico, United States, 87131-5636
    - University of New Mexico Cancer Center
- New York
  - Bronx, New York, United States, 10461
    - Albert Einstein Cancer Center at Albert Einstein College of Medicine
  - Middletown, New York, United States, 10940-4199
    - Tucker Center for Cancer Care at Orange Regional Medical Center
  - New York, New York, United States, 10065
    - Memorial Sloan-Kettering Cancer Center
  - New York, New York, United States, 10025
    - St. Luke's - Roosevelt Hospital Center - St.Luke's Division
  - New York, New York, United States, 10003-3803
    - Beth Israel Medical Center - Petrie Division
  - Rochester, New York, United States, 14642
    - James P. Wilmot Cancer Center at University of Rochester Medical Center
  - Syracuse, New York, United States, 13210
    - SUNY Upstate Medical University Hospital
- North Carolina
  - Goldsboro, North Carolina, United States, 27534
    - Wayne Memorial Hospital, Incorporated
  - Pinehurst, North Carolina, United States, 28374
    - FirstHealth Moore Regional Community Hospital Comprehensive Cancer Center
  - Rutherfordton, North Carolina, United States, 28139
    - Rutherford Hospital
  - Statesville, North Carolina, United States, 28677
    - Iredell Memorial Hospital
  - Winston-Salem, North Carolina, United States, 27157-1096
    - Wake Forest University Comprehensive Cancer Center
- North Dakota
  - Bismarck, North Dakota, United States, 58501
    - Medcenter One Hospital Cancer Care Center
  - Bismarck, North Dakota, United States, 58501
    - Mid Dakota Clinic, PC
  - Bismarck, North Dakota, United States, 58502
    - St. Alexius Medical Center Cancer Center
- Ohio
  - Akron, Ohio, United States, 44309-2090
    - Summa Center for Cancer Care at Akron City Hospital
  - Barberton, Ohio, United States, 44203
    - Barberton Citizens Hospital
  - Bowling Green, Ohio, United States, 43402
    - Wood County Oncology Center
  - Cleveland, Ohio, United States, 44195
    - Cleveland Clinic Taussig Cancer Center
  - Cleveland, Ohio, United States, 44106-5065
    - Case Comprehensive Cancer Center
  - Columbus, Ohio, United States, 43210-1240
    - Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center
  - Dayton, Ohio, United States, 45405
    - Grandview Hospital
  - Dayton, Ohio, United States, 45406
    - Good Samaritan Hospital
  - Dayton, Ohio, United States, 45409
    - David L. Rike Cancer Center at Miami Valley Hospital
  - Dayton, Ohio, United States, 45415
    - Samaritan North Cancer Care Center
  - Dayton, Ohio, United States, 45420
    - CCOP - Dayton
  - Elyria, Ohio, United States, 44035
    - Community Cancer Center
  - Elyria, Ohio, United States, 44035
    - Hematology Oncology Center
  - Findlay, Ohio, United States, 45840
    - Blanchard Valley Medical Associates
  - Franklin, Ohio, United States, 45005-1066
    - Middletown Regional Hospital
  - Greenville, Ohio, United States, 45331
    - Wayne Hospital
  - Kettering, Ohio, United States, 45429
    - Charles F. Kettering Memorial Hospital
  - Lima, Ohio, United States, 45804
    - Lima Memorial Hospital
  - Maumee, Ohio, United States, 43537-1839
    - Northwest Ohio Oncology Center
  - Oregon, Ohio, United States, 43616
    - St. Charles Mercy Hospital
  - Oregon, Ohio, United States, 43616
    - Toledo Clinic - Oregon
  - Sylvania, Ohio, United States, 43560
    - Flower Hospital Cancer Center
  - Tiffin, Ohio, United States, 44883
    - Mercy Hospital of Tiffin
  - Toledo, Ohio, United States, 43608
    - St. Vincent Mercy Medical Center
  - Toledo, Ohio, United States, 43606
    - Toledo Hospital
  - Toledo, Ohio, United States, 43614
    - Medical University of Ohio Cancer Center
  - Toledo, Ohio, United States, 43617
    - CCOP - Toledo Community Hospital
  - Toledo, Ohio, United States, 43623
    - Toledo Clinic, Incorporated - Main Clinic
  - Toledo, Ohio, United States, 43623
    - St. Anne Mercy Hospital
  - Troy, Ohio, United States, 45373-1300
    - UVMC Cancer Care Center at Upper Valley Medical Center
  - Wauseon, Ohio, United States, 43567
    - Fulton County Health Center
  - Xenia, Ohio, United States, 45385
    - Ruth G. McMillan Cancer Center at Greene Memorial Hospital
- Oregon
  - Clackamas, Oregon, United States, 97015
    - Clackamas Radiation Oncology Center
  - Gresham, Oregon, United States, 97030
    - Legacy Mount Hood Medical Center
  - Milwaukie, Oregon, United States, 97222
    - Providence Milwaukie Hospital
  - Newberg, Oregon, United States, 97132
    - Providence Newberg Medical Center
  - Oregon City, Oregon, United States, 97045
    - Willamette Falls Hospital
  - Portland, Oregon, United States, 97210
    - Legacy Good Samaritan Hospital & Comprehensive Cancer Center
  - Portland, Oregon, United States, 97213-2967
    - Providence Cancer Center at Providence Portland Medical Center
  - Portland, Oregon, United States, 97225
    - CCOP - Columbia River Oncology Program
  - Portland, Oregon, United States, 97225
    - Providence St. Vincent Medical Center
  - Portland, Oregon, United States, 97227
    - Legacy Emanuel Hospital and Health Center and Children's Hospital
  - Tualatin, Oregon, United States, 97062
    - Legacy Meridian Park Hospital
- Pennsylvania
  - Allentown, Pennsylvania, United States, 18105
    - Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest
  - Danville, Pennsylvania, United States, 17822-0001
    - Geisinger Cancer Institute at Geisinger Health
  - Hazleton, Pennsylvania, United States, 18201
    - Geisinger Hazleton Cancer Center
  - Hershey, Pennsylvania, United States, 17033-0850
    - Penn State Hershey Cancer Institute at Milton S. Hershey Medical Center
  - Lewistown, Pennsylvania, United States, 17044
    - Lewistown Hospital
  - Philadelphia, Pennsylvania, United States, 19107
    - Joan Karnell Cancer Center at Pennsylvania Hospital
  - State College, Pennsylvania, United States, 16803
    - Mount Nittany Medical Center
  - State College, Pennsylvania, United States, 16801
    - Geisinger Medical Group - Scenery Park
  - Wilkes-Barre, Pennsylvania, United States, 18711
    - Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center
- South Carolina
  - Anderson, South Carolina, United States, 29621
    - AnMed Cancer Center
  - Charleston, South Carolina, United States, 29425
    - Hollings Cancer Center at Medical University of South Carolina
  - Greenville, South Carolina, United States, 29601
    - Bon Secours St. Francis Health System
  - Spartanburg, South Carolina, United States, 29303
    - CCOP - Upstate Carolina
  - Spartanburg, South Carolina, United States, 29303
    - Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
- South Dakota
  - Sioux Falls, South Dakota, United States, 57117-5039
    - Sanford Cancer Center at Sanford USD Medical Center
- Tennessee
  - Jackson, Tennessee, United States, 38301
    - West Tennessee Cancer Center at Jackson-Madison County General Hospital
  - Nashville, Tennessee, United States, 37232-6838
    - Vanderbilt-Ingram Cancer Center
- Texas
  - Dallas, Texas, United States, 75390
    - Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
  - Houston, Texas, United States, 77030-4009
    - M. D. Anderson Cancer Center at University of Texas
- Vermont
  - Berlin, Vermont, United States, 05602
    - Mountainview Medical
  - Burlington, Vermont, United States, 05401
    - Fletcher Allen Health Care - University Health Center Campus
- Virginia
  - Fredericksburg, Virginia, United States, 22401
    - Fredericksburg Oncology, Incorporated
  - Martinsville, Virginia, United States, 24115
    - Ravenel Oncology Center at Memorial Hospital of Martinsville and Henry County
- Washington
  - Anacortes, Washington, United States, 98221
    - Island Hospital Cancer Care Center at Island Hospital
  - Bellevue, Washington, United States, 98004
    - Overlake Cancer Center at Overlake Hospital Medical Center
  - Bellingham, Washington, United States, 98225
    - St. Joseph Cancer Center
  - Bremerton, Washington, United States, 98310
    - Olympic Hematology and Oncology
  - Burien, Washington, United States, 98166
    - Highline Medical Center Cancer Center
  - Centralia, Washington, United States, 98531-9027
    - Providence Centralia Hospital
  - Everett, Washington, United States, 98201
    - Providence Regional Cancer Partnership
  - Federal Way, Washington, United States, 98003
    - St. Francis Hospital
  - Issaquah, Washington, United States, 98029
    - Swedish Medical Center - Issaquah Campus
  - Kennewick, Washington, United States, 99336
    - Columbia Basin Hematology
  - Mount Vernon, Washington, United States, 98274
    - Skagit Valley Hospital Cancer Care Center
  - Olympia, Washington, United States, 98506-5166
    - Providence St. Peter Hospital Regional Cancer Center
  - Poulsbo, Washington, United States, 98370
    - Harrison Poulsbo Hematology and Onocology
  - Puyallup, Washington, United States, 98372
    - Good Samaritan Cancer Center
  - Seattle, Washington, United States, 98109
    - Fred Hutchinson Cancer Research Center
  - Seattle, Washington, United States, 98104
    - Harborview Medical Center
  - Seattle, Washington, United States, 98104
    - Minor and James Medical, PLLC
  - Seattle, Washington, United States, 98112
    - Group Health Central Hospital
  - Seattle, Washington, United States, 98122-4307
    - Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
  - Seattle, Washington, United States, 98122
    - Polyclinic First Hill
  - Seattle, Washington, United States, 98195
    - University Cancer Center at University of Washington Medical Center
  - Sedro-Woolley, Washington, United States, 98284
    - North Puget Oncology at United General Hospital
  - Spokane, Washington, United States, 99202
    - Cancer Care Northwest - Spokane South
  - Spokane, Washington, United States, 99218
    - Evergreen Hematology and Oncology, PS
  - Tacoma, Washington, United States, 98405-3004
    - Franciscan Cancer Center at St. Joseph Medical Center
  - Tacoma, Washington, United States, 98405
    - Allenmore Hospital
  - Tacoma, Washington, United States, 98405
    - CCOP - Northwest
  - Tacoma, Washington, United States, 98405
    - MultiCare Regional Cancer Center at Tacoma General Hospital
  - Tacoma, Washington, United States, 98499
    - St. Clare Hospital
  - Tacoma, Washington, United States, 98431
    - Madigan Army Medical Center - Tacoma
  - Vancouver, Washington, United States, 98684
    - Northwest Cancer Specialists at Vancouver Cancer Center
  - Vancouver, Washington, United States, 98686
    - Legacy Salmon Creek Medical Center
  - Vancouver, Washington, United States, 98664
    - Southwest Washington Medical Center Cancer Center
  - Wenatchee, Washington, United States, 98801-2028
    - Wenatchee Valley Medical Center
- West Virginia
  - Morgantown, West Virginia, United States, 26506
    - Mary Babb Randolph Cancer Center at West Virginia University Hospitals
- Wisconsin
  - Eau Claire, Wisconsin, United States, 54701
    - Center for Cancer Treatment & Prevention at Sacred Heart Hospital
  - Eau Claire, Wisconsin, United States, 54701
    - Marshfield Clinic Cancer Care at Regional Cancer Center
  - Green Bay, Wisconsin, United States, 54307-3508
    - St. Vincent Hospital Regional Cancer Center
  - Green Bay, Wisconsin, United States, 54301-3526
    - Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center
  - Green Bay, Wisconsin, United States, 54303
    - Green Bay Oncology, Limited at St. Mary's Hospital
  - Green Bay, Wisconsin, United States, 54303
    - St. Mary's Hospital Medical Center - Green Bay
  - Johnson Creek, Wisconsin, United States, 53038
    - UW Cancer Center Johnson Creek
  - La Crosse, Wisconsin, United States, 54601
    - Gundersen Lutheran Center for Cancer and Blood
  - Madison, Wisconsin, United States, 53792-6164
    - University of Wisconsin Paul P. Carbone Comprehensive Cancer Center
  - Manitowoc, Wisconsin, United States, 54221-1450
    - Holy Family Memorial Medical Center Cancer Care Center
  - Marinette, Wisconsin, United States, 54143
    - Bay Area Cancer Care Center at Bay Area Medical Center
  - Marshfield, Wisconsin, United States, 54449
    - Saint Joseph's Hospital
  - Marshfield, Wisconsin, United States, 54449
    - Marshfield Clinic - Marshfield Center
  - Minocqua, Wisconsin, United States, 54548
    - Marshfield Clinic - Lakeland Center
  - Mukwonago, Wisconsin, United States, 53149
    - D.N. Greenwald Center
  - Oconomowoc, Wisconsin, United States, 53066
    - Regional Cancer Center at Oconomowoc Memorial Hospital
  - Oconto Falls, Wisconsin, United States, 54154
    - Green Bay Oncology, Limited - Oconto Falls
  - Rhinelander, Wisconsin, United States, 54501
    - Ministry Medical Group at Saint Mary's Hospital
  - Rice Lake, Wisconsin, United States, 54868
    - Marshfield Clinic - Indianhead Center
  - Sheboygan, Wisconsin, United States, 53081
    - St. Nicholas Hospital
  - Stevens Point, Wisconsin, United States, 54481
    - Marshfield Clinic at Saint Michael's Hospital
  - Stevens Point, Wisconsin, United States, 54481
    - Saint Michael's Hospital Cancer Center
  - Sturgeon Bay, Wisconsin, United States, 54235
    - Green Bay Oncology, Limited - Sturgeon Bay
  - Waukesha, Wisconsin, United States, 53188
    - Waukesha Memorial Hospital Regional Cancer Center
  - Weston, Wisconsin, United States, 54476
    - Diagnostic and Treatment Center
  - Weston, Wisconsin, United States, 54476
    - Marshfield Clinic - Weston Center
  - Weston, Wisconsin, United States, 54476
    - Ministry Saint Clare's Hospital
  - Wisconsin Rapids, Wisconsin, United States, 54494
    - Marshfield Clinic - Wisconsin Rapids Center
- Wyoming
  - Casper, Wyoming, United States, 82609
    - Rocky Mountain Oncology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

DISEASE CHARACTERISTICS:

Histologically confirmed classical Hodgkin lymphoma (HL) (i.e., nodular sclerosis, mixed cellularity, lymphocyte-rich, or lymphocyte-depleted)
- Previously untreated stage III or IV disease
- No nodular lymphocyte predominant disease
Bidimensionally measurable disease
Adequate biopsy samples from original diagnostic specimen must be available for pathologic review
- Tissue obtained from core biopsies allowed
- No tissue obtained from needle aspirations or cytologies
Must have known HIV status
- No multi-drug resistant HIV infection, CD4 counts < 150/μL, or other concurrent AIDS-defining conditions in HIV-positive patients
- HIV-positive patients with CD4 counts ≥ 150/μL at the time of enrollment OR documented CD4 count > 250/μL at any time within 8 months prior to HL diagnosis allowed
Must have undergone unilateral or bilateral bone marrow biopsy within the past 42 days
Must have a diagnostic quality CT scan of the chest/abdomen and pelvis AND baseline FDG-PET scan within the past 28 days
- Combined PET/CT scans required
- No older "stand-alone" FDG-PET scans
- No low-resolution "localization" CT scans as part of a combined PET/CT scans

PATIENT CHARACTERISTICS:

Zubrod performance status 0-2
Serum erythrocyte sedimentation rate, lactate dehydrogenase (LDH), hemoglobin, albumin, white blood cell count (WBC), and lymphocytes measured within the past 28 days
Serum estradiol (women only), testosterone (men only), follicle stimulating hormone (FSH) and luteinizing hormone (LH) (both men and women) levels must be drawn within 60 days prior to registration
Not pregnant or nursing
Fertile patients must use effective contraception during and for ≥ 6 months after completion of study therapy
No significant cardiac abnormalities as assessed by multiple gated acquisition scan (MUGA) or ECHO AND cardiac ejection fraction ≥ 45% in patients with a history of hypertension or cardiac symptoms
Hepatitis B-negative (i.e., hepatitis B surface antigen-negative or anti-hepatitis B core antigen-negative)
- Patients immune to or immunized against hepatitis B (i.e., anti-hepatitis B surface antibody-positive) are eligible
Hepatitis C-negative (i.e., anti-hepatitis C antibody-negative)
No significant lung disease with abnormal lung function tests (i.e., diffusing capacity of lung for carbon monoxide (DLCO) > 25% below predicted after correction for hemoglobin) unless attributable to lymphoma
No requirement for continuous supplemental oxygen therapy
No other prior malignancy except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease-free for 5 years

PRIOR CONCURRENT THERAPY:

See Disease Characteristics
No prior chemotherapy, radiotherapy, or antibody therapy for lymphoma
No prior solid organ transplantation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Interventional Model: Parallel Assignment
Masking: None (Open Label)

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HIV Positive, PET Positive: BEACOPP standard Etoposide 100 mg/m2 IV Days 1, 2, 3 Dox 25 mg/m2 IV Day 1 Cyclo 650mg/m2 IV Day 1 Procarb 100 mg/m2 PO Days 1-7 Pred 40 mg/m2 PO Days 1-14 Bleo 10u/m2 IV Day 8 Vincristine 1.4 mg/m2 IV Day 8 Q 21 Days x 6 cycles	Drug: cyclophosphamide Drug: prednisone Drug: etoposide Drug: vincristine sulfate Drug: doxorubicin hydrochloride Drug: procarbazine hydrochloride Biological: bleomycin sulfate Drug: BEACOPP regimen
Experimental: HIV Negative, PET Positive: BEACOPP escalated Etoposide 200 mg/m2 IV Days 1, 2, 3 Dox 35 mg/m2 IV Day 1 Cyclo 1,250 mg/m2 IV Day 1 Procarb 100 mg/m2 PO Days 1-7 Pred 40 mg/m2 PO Days 1-14 Bleo 10u/m2 IV Day 8 Vincristine 1.4 mg/m2 IV Day 8 G-CSF 5mcg/kg/day SQ Days 8-14 Q 21 Days x 6 cycles	Drug: cyclophosphamide Drug: prednisone Drug: etoposide Drug: vincristine sulfate Drug: doxorubicin hydrochloride Biological: filgrastim Drug: procarbazine hydrochloride Biological: bleomycin sulfate Drug: BEACOPP regimen
Active Comparator: HIV Positive, PET Negative: ABVD Doxorubicin 25 mg/m2 IV Bleomycin 10u/m2 IV Vinblastine 6mg/m2 IV Dacarbazine 375 mg/m2 IV Days 1, 15 Q 28 Days x 2	Drug: doxorubicin hydrochloride Drug: dacarbazine Drug: vinblastine sulfate Biological: bleomycin sulfate Drug: ABVD regimen
Active Comparator: HIV Negative, PET Negative: ABVD Doxorubicin 25 mg/m2 IV Bleomycin 10u/m2 IV Vinblastine 6mg/m2 IV Dacarbazine 375 mg/m2 IV Days 1, 15 Q 28 Days x 2	Drug: doxorubicin hydrochloride Drug: dacarbazine Drug: vinblastine sulfate Biological: bleomycin sulfate Drug: ABVD regimen

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of HIV-negative Patients With 2-year Progression-free Survival (PFS) Treated With 2 Initial Cycles of Adriamycin, Bleomycin, Vnblastine, and Dacarbazine (ABVD) Followed by Response-adapted Therapy Based on Interim FDG-PET Imaging. Time Frame: 2 years	Disease progression is defined using the 2007 revised Cheson et al. criteria that is at least 50% increase in sum of the product of the diameters (SPD) of target measurable nodal lesions over the smallest sum observed, or >= 50% increase in greatest transverse diameter (GTD) of any nodal > 1 cm in shortest axis, or >= 50% increase in the SPD of other target measurable lesions over the smallest sum observed, any new bone marrow involvement, any new lesion, lymph node with long axis is > 1.5 cm or if both long and short axes are > 1 cm, PET positive if patients with no pretreatment PET scan or when PET scan was positive before therapy. Progression-free survival is measured from date of registration to date of first observation of progressive disease, or death due to any cause. Patients last known to be alive and progression-free are censored at date of last contact.	2 years
Percentage of HIV-negative Patients Who Are PET-positive After 2 Cycles of ABVD With 2-year PFS Time Frame: 2 years	Disease progression is defined using the 2007 revised Cheson et al. criteria that is at least 50% increase in sum of the product of the diameters (SPD) of target measurable nodal lesions over the smallest sum observed, or >= 50% increase in greatest transverse diameter (GTD) of any nodal > 1 cm in shortest axis, or >= 50% increase in the SPD of other target measurable lesions over the smallest sum observed, any new bone marrow involvement, any new lesion, lymph node with long axis is > 1.5 cm or if both long and short axes are > 1 cm, PET positive if patients with no pretreatment PET scan or when PET scan was positive before therapy. Progression-free survival is measured from date of registration to date of first observation of progressive disease, or death due to any cause. Patients last known to be alive and progression-free are censored at date of last contact.	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of HIV-negative Patients With 2-year Overall Survival (OS) Treated With 2 Initial Cycles of ABVD Followed by Response-Adapted Therapy Based on Interim FDG-PET Imaging Time Frame: 2 years	Measured from date of registration to date of death due to any cause. Patients last known to be alive and are censored at date of last contact.	2 years
Complete and Partial Response Rates for HIV-negative Patients Treated With Response- Adapted Therapy Based on FDG-PET Imaging After 2 Cycles of ABVD Time Frame: 7 months after registration	Complete Response (CR) is a complete disappearance of all disease with the exception of the following. If no PET scan or when the PET scan was positive before therapy, a post-treatment residual mass of any size is permitted if it is PET negative. If the PET scan was negative before therapy, all nodal masses at baseline must have regressed. No new lesions. Previously enlarged organs must have regressed and not be palpable. Bone marrow (BM) must be negative if positive at baseline. Normalization of markers. Partial Response (PR) is a 50% decrease in the sum of products of greatest diameters (SPD) for up to 6 identified dominant lesions, including spleenic and hepatic nodules from baseline. No new lesions and no increase in the size of liver, spleen or other nodes. If PET scan or when the PET scan was positive before therapy, PET should be positive in at least one previously involved site.	7 months after registration
Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug Time Frame: Up to 1 year	Adverse Events (AEs) are reported by the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. For each patient, worst grade of each event type is reported. Grade 3 = Severe, Grade 4 = Life-threatening, Grade 5 = Fatal.	Up to 1 year
Percentage of HIV-positive Patients With 2-year Progression-free Survival (PFS) Treated With Initial 2 Cycles of Adriamycin, Bleomycin, Vnblastine, and Dacarbazine (ABVD) Followed by Response-adapted Therapy Based on Interim FDG-PET Imaging. Time Frame: 2 years	Disease progression is defined using the 2007 revised Cheson et al. criteria that is at least 50% increase in sum of the product of the diameters (SPD) of target measurable nodal lesions over the smallest sum observed, or >= 50% increase in greatest transverse diameter (GTD) of any nodal > 1 cm in shortest axis, or >= 50% increase in the SPD of other target measurable lesions over the smallest sum observed, any new bone marrow involvement, any new lesion, lymph node with long axis is >1.5 cm or if both long and short axes are > 1 cm, PET positive if patients with no pretreatment PET scan or when PET scan was positive before therapy. progression-free survival is measured from date of registration to date of first observation of progressive disease, or death due to any cause. Patients last known to be alive and progression-free are censored at date of last contact.	2 years
Percentage of HIV-positive Patients With 5-year Overall Survival (OS) Treated With 2 Initial Cycles of ABVD Followed by Response-Adapted Therapy Based on Interim FDG-PET Imaging. Time Frame: 5 years	Measured from date of registration to date of death due to any cause. Patients last known to be alive and are censored at date of last contact.	5 years
Complete and Partial Response Rates for HIV-positive Patients Treated With Response-Adapted Therapy Based on FDG-PET Imaging After 2 Cycles of ABVD Time Frame: 7 months after registration	Complete Response (CR) is a complete disappearance of all disease with the exception of the following. If no PET scan or when the PET scan was positive before therapy, a post-treatment residual mass of any size is permitted if it is PET negative. If the PET scan was negative before therapy, all nodal masses at baseline must have regressed. No new lesions. Previously enlarged organs must have regressed and not be palpable. Bone marrow (BM) must be negative if positive at baseline. Normalization of markers. Partial Response (PR) is a 50% decrease in the sum of products of greatest diameters (SPD) for up to 6 identified dominant lesions, including spleenic and hepatic nodules from baseline. No new lesions and no increase in the size of liver, spleen or other nodes. If PET scan or when the PET scan was positive before therapy, PET should be positive in at least one previously involved site.	7 months after registration
Number of HIV-positive Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug Time Frame: Up to 1 year	Adverse Events (AEs) are reported by the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. For each patient, worst grade of each event type is reported. Grade 3 = Severe, Grade 4 = Life-threatening, Grade 5 = Fatal.	Up to 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Southwest Oncology Group

Collaborators

National Cancer Institute (NCI)

Investigators

Study Chair: Oliver W. Press, MD, PhD, Fred Hutchinson Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2009

Primary Completion (Actual)

April 30, 2016

Study Completion (Actual)

June 30, 2022

Study Registration Dates

First Submitted

January 13, 2009

First Submitted That Met QC Criteria

January 13, 2009

First Posted (Estimate)

January 14, 2009

Study Record Updates

Last Update Posted (Actual)

August 18, 2022

Last Update Submitted That Met QC Criteria

August 16, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

CDR0000630501
U10CA032102 (U.S. NIH Grant/Contract)
S0816 (Other Identifier: SWOG)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Follicular Lymphoma | Mantle Cell Lymphoma | Marginal Zone Lymphoma | Non-Hodgkin Lymphoma | DLBCL

United States, Korea, Republic of, Spain, France, Australia, Czechia, Italy
Massachusetts General Hospital
TG Therapeutics

Active, not recruiting

Umbralisib and Rituximab as Initial Therapy for Patients With Follicular Lymphoma and Marginal Zone Lymphoma

Lymphoma | Follicular Lymphoma | Marginal Zone Lymphoma | Follicular Lymphoma, Grade 1 | Follicular Lymphoma Grade IIIa | Marginal Zone B Cell Lymphoma | Follicular Lymphoma Grade 2

United States
Fred Hutchinson Cancer Center
National Cancer Institute (NCI)

Completed

Bortezomib and Vorinostat as Maintenance Therapy After Autologous Stem Cell Transplant in Treating Patients With Non-Hodgkin Lymphoma

Follicular Lymphoma | Mantle Cell Lymphoma | Non-Hodgkin Lymphoma | B-Cell Non-Hodgkin Lymphoma | Adult Diffuse Large B-Cell Lymphoma | T-Cell Non-Hodgkin Lymphoma

United States
Children's Oncology Group
National Cancer Institute (NCI)

Completed

Collecting and Storing Tissue Samples From Patients With Rare or Cutaneous Non-Hodgkin Lymphoma

Mantle Cell Lymphoma | Marginal Zone Lymphoma | Non-Hodgkin Lymphoma | Small Lymphocytic Lymphoma | Lymphoproliferative Disorder | Primary Cutaneous B-Cell Non-Hodgkin Lymphoma | Grade 1 Follicular Lymphoma | Grade 2 Follicular Lymphoma | Primary Cutaneous T-Cell Non-Hodgkin Lymphoma | Grade 3 Follicular... and other conditions

United States, Canada, Australia, Puerto Rico
Massachusetts General Hospital
National Comprehensive Cancer Network

Completed

Carfilzomib Plus Belinostat in Relapsed/Refractory NHL

Follicular Lymphoma | Mantle Cell Lymphoma | Non-Hodgkin Lymphoma | Peripheral T-cell Lymphoma | Diffuse Large B-cell Lymphoma

United States
Novartis Pharmaceuticals

Completed

Safety and Efficacy of BKM120 in Relapsed and Refractory NHL

Diffuse Large B-cell Lymphoma, Mantle Cell Lymphoma, Follicular Lymphoma

United States, Belgium, Germany, France, Italy, Korea, Republic of, Spain, Turkey
Ruijin Hospital
The First Affiliated Hospital with Nanjing Medical University; Shanxi Province... and other collaborators

Not yet recruiting

A Retrospective Study on Extranodal Lymphoma or Lymphoma of Rare Pathological Types

Lymphoma | Marginal Zone Lymphoma | Anaplastic Large Cell Lymphoma | Angioimmunoblastic T-cell Lymphoma | Diffuse Large B Cell Lymphoma | Mucosa-Associated Lymphoid Tissue Lymphoma | Intravascular Large B-Cell Lymphoma | Extranodal Lymphoma | NK/T-Cell Lymphoma, Nasal and Nasal-Type

China

Clinical Trials on cyclophosphamide

Children's Hospital Los Angeles
Lucile Packard Children's Hospital

Terminated

Related Hematopoietic Stem Cell Transplantation (HSCT) for Genetic Diseases of Blood Cells

Metabolic Diseases | Stem Cell Transplantation | Chronic Granulomatous Disease | Bone Marrow Transplantation | Thalassemia | Wiskott-Aldrich Syndrome | Genetic Diseases | Peripheral Blood Stem Cell Transplantation | Pediatrics | Diamond-Blackfan Anemia | Allogeneic Transplantation | Combined Immune Deficiency | X-linked Lymphoproliferative Disease
Medical College of Wisconsin
National Cancer Institute (NCI); National Heart, Lung, and Blood Institute... and other collaborators

Completed

Fludarabine-based Conditioning for Severe Aplastic Anemia (BMT CTN 0301)

Anemia, Aplastic

United States
Columbia University

Unknown

Risk-Adapted Allogeneic Stem Cell Transplantation For Mixed Donor Chimerism In Patients With Non-Malignant Diseases

Severe Combined Immunodeficiency | Fanconi Anemia | Bone Marrow Failure | Osteopetrosis

United States
National Cancer Institute, Naples
Immatics Biotechnologies GmbH; CureVac; European Commission -FP7-Health-2013-Innovation-1

Completed

IMA970A Plus CV8102 in Very Early, Early and Intermediate Stage Hepatocellular Carcinoma Patients

Hepatocellular Carcinoma

Belgium, Germany, Italy, Spain, United Kingdom
Eisai Inc.

Completed

A Study of ZYC300 Administered With Cyclophosphamide Pre-Dosing

Breast Cancer | Ovarian Cancer | Prostate Cancer | Colon Cancer | Renal Cancer

United States
Centre Oscar Lambret

Completed

Imatinib Mesylate And Cyclophosphamide In Metronomic Administration: Dose Escalation Study Of Imatinib Mesylate (PALANGI3)

Cancer

France
Mahidol University

Terminated

Low-dose VS High-dose IV Cyclophosphamide for Proliferative LN in Children (Low/highIVCY)

Renal Insufficiency | Infection

Thailand
Baylor Research Institute

Completed

Combined Modality Treatment for Patients With Stage IV Melanoma

Malignant Melanoma Stage IV

United States
University of Turin, Italy

Unknown

Letrozole Plus Oral Cyclophosphamide Plus/Minus Sorafenib as Primary Systemic Treatment in Breast Cancer Patients

Breast Cancer

Italy
Merck KGaA, Darmstadt, Germany

Completed

Study of Tecemotide (L-BLP25) in Subjects With Slowly Progressive Multiple Myeloma With no Symptoms and Who Have Had no Chemotherapy

Multiple Myeloma

Germany

S0816 Fludeoxyglucose F 18-PET/CT Imaging and Combination Chemotherapy With or Without Additional Chemotherapy and G-CSF in Treating Patients With Stage III or Stage IV Hodgkin Lymphoma

A Phase II Trial of Response-Adapted Therapy of Stage III-IV Hodgkin Lymphoma Using Early Interim FDG-PET Imaging

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Clinical Trials on Lymphoma

Clinical Trials on cyclophosphamide

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