- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01132807
Chemotherapy Based on Positron Emission Tomography Scan in Treating Patients With Stage I or Stage II Hodgkin Lymphoma
Phase II Trial of Response-Adapted Chemotherapy Based on Positron Emission Tomography for Non-Bulky Stage I and II Hodgkin Lymphoma
Study Overview
Status
Conditions
Intervention / Treatment
- Drug: Cyclophosphamide
- Drug: Dacarbazine
- Drug: Doxorubicin Hydrochloride
- Drug: Vinblastine Sulfate
- Drug: prednisone
- Procedure: Positron Emission Tomography
- Biological: Bleomycin Sulfate
- Drug: Procarbazine Hydrochloride
- Radiation: Fludeoxyglucose F-18
- Drug: Etoposide phosphate
- Drug: Radiation Therapy
- Procedure: computed tomography
Detailed Description
PRIMARY OBJECTIVES:
I. To determine the progression-free survival (PFS) from enrollment for patients with non-bulky stage I and II Hodgkin lymphoma.
II. To compare the PFS of patients who are PET positive versus PET negative following 2 cycles of doxorubicin hydrochloride, bleomycin, vinblastine, and dacarbazine (ABVD).
SECONDARY OBJECTIVES:
I. To evaluate the complete response (CR) rate of patients diagnosed with non-bulky stage I and II Hodgkin lymphoma following PET response-adapted chemotherapy with or without radiation therapy.
II. To determine the predictive value of fludeoxyglucose (FDG) uptake using various semi-quantitative approaches, at baseline, after 2 cycles of AVBD and at completion of therapy.
III. To determine the predictive value of volumetric changes on computed tomography (CT) vs 2-dimensional (2-D) analyses after 2 cycles and 4 cycles and compare with PET parameters with and without combination analyses (PET + dedicated CT data).
IV. To compare the predictive value of metabolic parameters/changes that are measured both visually and semi-quantitatively, International Harmonization Project (IHP) criteria, 2-D and volumetric CT changes, molecular parameters, and conventional parameters, including International Prognostic Score (IPS).
V. To assess whether elevated baseline circulating markers of inflammation (including soluble cluster of differentiation CD30 [sCD]30, soluble CD 163 [CD163], interleukin-10 (IL10), chemokine (C-C motif) ligand 17 (CCL17), and chemokine (C-C motif) ligand 22 [CCL22]) correlate with clinical response and PFS and PET scan results.
VI. To assess whether persistent or recurrent elevated serial circulating markers of inflammation (including soluble CD30 [sCD30], soluble CD163 [sCD163], IL10, CCL17, or CCL22) correlate with relapse/progression or PET scan results.
VII. To confirm independently useful tissue biomarkers for risk stratification in patients with non-bulky stage I and II Hodgkin lymphoma treated with this regimen.
VIII. To compare mediastinal bulk on standing posterior-anterior (PA) and lateral chest x-ray (> 0.33 maximum chest diameter) with chest CT (mass > 10 cm).
OUTLINE:
ABVD CHEMOTHERAPY: Patients receive doxorubicin hydrochloride intravenously (IV) over 3-5 minutes, bleomycin sulfate IV over 3-5 minutes, vinblastine IV over 3-5 minutes, and dacarbazine IV over 30 minutes on days 1 and 15. Treatment repeats every 28 days for 2 courses. Patients then undergo PET scan. Patients achieving complete response (CR), partial response (PR), or stable disease (SD) with a negative PET scan receive 2 additional courses of ABVD chemotherapy in the absence of disease progression or unacceptable toxicity. Patients achieving CR, PR, or SD with a positive PET scan proceed to escalated BEACOPP chemotherapy.
ESCALATED BEACOPP* CHEMOTHERAPY: Patients receive doxorubicin hydrochloride IV over 3-5 minutes and cyclophosphamide IV over 60 minutes on day 1, etoposide IV over 45-60 minutes on days 1-3, procarbazine orally (PO) on days 1-7, prednisone PO on days 1-14, and bleomycin sulfate IV and vincristine IV on day 8. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. Within 4-6 weeks after completion of BEACOPP chemotherapy, patients undergo involved-field radiotherapy (IFRT) 5 days a week for 3½ weeks.
NOTE: * HIV-positive patients receive standard BEACOPP instead of escalated BEACOPP.
Patients undergo fludeoxyglucose F^18 PET/CT scan at baseline, and within 8-10 days after completion of chemotherapy. Patients also undergo additional PET/CT scans within 3-4 weeks after completion of ABVD or within 12 weeks after completion of BEACOPP and IFRT. Patients with a negative PET scan proceed to follow up. Patients with a positive PET scan undergo biopsy**. Patients with a negative biopsy proceed to follow up, and patients with a positive biopsy are treated at the discretion of the investigator.
NOTE: ** Patients for whom biopsy is neither clinically appropriate nor medically feasible proceed to follow-up. Patients for whom biopsy is neither clinically indicated nor medically appropriate undergo a repeat PET/CT scan after 3 months. If PET/CT scan remains positive, patients undergo biopsy as above.
After completion of study therapy, patients are followed up every 3 months for 1 year, every 6 months for 2-3 years, and then annually for a maximum of 5 years.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Arizona
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Tucson, Arizona, United States, 85724-5024
- Arizona Cancer Center at University of Arizona Health Sciences Center
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California
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Duarte, California, United States, 91010-3000
- City of Hope Comprehensive Cancer Center
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Connecticut
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New Haven, Connecticut, United States, 06520-8028
- Yale Cancer Center
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Delaware
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Newark, Delaware, United States, 19713
- CCOP - Christiana Care Health Services
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District of Columbia
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Washington, District of Columbia, United States, 20007
- Lombardi Comprehensive Cancer Center at Georgetown University Medical Center
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Florida
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Orlando, Florida, United States, 32806
- M.D. Anderson Cancer Center at Orlando
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Georgia
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Augusta, Georgia, United States, 30912
- MBCCOP - Medical College of Georgia Cancer Center
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Hawaii
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'Aiea, Hawaii, United States, 96701
- Kapiolani Medical Center at Pali Momi
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'Aiea, Hawaii, United States, 96701
- Oncare Hawaii, Incorporated - Pali Momi
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Honolulu, Hawaii, United States, 96817
- Kuakini Medical Center
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Honolulu, Hawaii, United States, 96826
- Kapiolani Medical Center for Women and Children
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Honolulu, Hawaii, United States, 96813
- OnCare Hawaii, Incorporated - Lusitana
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Honolulu, Hawaii, United States, 96813
- Queen's Cancer Institute at Queen's Medical Center
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Honolulu, Hawaii, United States, 96813
- Straub Clinic and Hospital, Incorporated
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Honolulu, Hawaii, United States, 96817-3169
- OnCare Hawaii, Incorporated - Kuakini
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Kailua, Hawaii, United States, 96734
- Castle Medical Center
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Lihue, Hawaii, United States, 96766
- Kauai Medical Clinic
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Illinois
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Chicago, Illinois, United States, 60637-1470
- University of Chicago Cancer Research Center
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Chicago, Illinois, United States, 60640
- Louis A. Weiss Memorial Hospital
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Chicago, Illinois, United States, 60611-3013
- Robert H. Lurie Comprehensive Cancer Center at Northwestern University
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Chicago, Illinois, United States, 60608
- Mount Sinai Hospital Medical Center
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Chicago, Illinois, United States, 60612-3785
- John H. Stroger, Jr. Hospital of Cook County
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Decatur, Illinois, United States, 62526
- Decatur Memorial Hospital Cancer Care Institute
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Evanston, Illinois, United States, 60201-1781
- Evanston Hospital
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Maywood, Illinois, United States, 60153
- Cardinal Bernardin Cancer Center at Loyola University Medical Center
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Iowa
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Ames, Iowa, United States, 50010
- McFarland Clinic, PC
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Sioux City, Iowa, United States, 51101
- Siouxland Hematology-Oncology Associates, LLP
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Kansas
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Wichita, Kansas, United States, 67214
- CCOP - Wichita
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Kentucky
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Lexington, Kentucky, United States, 40536-0093
- Lucille P. Markey Cancer Center at University of Kentucky
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Louisville, Kentucky, United States, 40202
- Louisville Oncology at Norton Cancer Institute - Louisville
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Louisville, Kentucky, United States, 40207
- Norton Suburban Hospital
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Louisiana
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Baton Rouge, Louisiana, United States, 70809
- Mary Bird Perkins Cancer Center - Baton Rouge
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New Orleans, Louisiana, United States, 70112
- MBCCOP - LSU Health Sciences Center
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New Orleans, Louisiana, United States, 70112
- Medical Center of Louisiana - New Orleans
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Maine
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Bangor, Maine, United States, 04401
- CancerCare of Maine at Eastern Maine Medical Center
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Maryland
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Baltimore, Maryland, United States, 21231-2410
- Sidney kimmel comprehensive cancer center at johns hopkins
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Baltimore, Maryland, United States, 21201
- Greenebaum Cancer Center at University of Maryland Medical Center
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Elkton, Maryland, United States, 21921
- Union Hospital of Cecil County
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Massachusetts
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Boston, Massachusetts, United States, 02115
- Dana-Farber/Harvard Cancer Center at Dana-Farber Cancer Institute
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Worcester, Massachusetts, United States, 01655
- UMASS Memorial Cancer Center - University Campus
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Michigan
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Adrian, Michigan, United States, 49221
- Hickman Cancer Center at Bixby Medical Center
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Ann Arbor, Michigan, United States, 48106-0995
- Saint Joseph Mercy Cancer Center
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Kalamazoo, Michigan, United States, 49007-3731
- West Michigan Cancer Center
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Minnesota
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Duluth, Minnesota, United States, 55805
- CCOP - Duluth
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Robbinsdale, Minnesota, United States, 55422-2900
- Humphrey Cancer Center at North Memorial Outpatient Center
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Saint Paul, Minnesota, United States, 55101
- Regions Hospital Cancer Care Center
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Missouri
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Saint Louis, Missouri, United States, 63131
- Missouri Baptist Cancer Center
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Saint Louis, Missouri, United States, 63110
- Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
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Montana
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Billings, Montana, United States, 59107-7000
- Billings Clinic - Downtown
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Nebraska
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Omaha, Nebraska, United States, 68198-6805
- UNMC Eppley Cancer Center at the University of Nebraska Medical Center
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Nevada
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Las Vegas, Nevada, United States, 89102
- University Medical Center of Southern Nevada
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New Hampshire
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Lebanon, New Hampshire, United States, 03756-0002
- Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
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New York
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Lake Success, New York, United States, 11042
- Monter Cancer Center of the North Shore-LIJ Health System
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Manhasset, New York, United States, 11030
- CCOP - North Shore University Hospital
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Manhasset, New York, United States, 11030
- Don Monti Comprehensive Cancer Center at North Shore University Hospital
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New Hyde Park, New York, United States, 11040
- Long Island Jewish Medical Center
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New York, New York, United States, 10065
- Memorial Sloan-Kettering Cancer Center
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New York, New York, United States, 10021
- New York Weill Cornell Cancer Center at Cornell University
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Rochester, New York, United States, 14642
- James P. Wilmot Cancer Center at University of Rochester Medical Center
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Syracuse, New York, United States, 13210
- SUNY Upstate Medical University Hospital
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North Carolina
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Charlotte, North Carolina, United States, 28232-2861
- Blumenthal Cancer Center at Carolinas Medical Center
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Charlotte, North Carolina, United States, 28233-3549
- Presbyterian Cancer Center at Presbyterian Hospital
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Goldsboro, North Carolina, United States, 27534
- Wayne Memorial Hospital, Incorporated
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Statesville, North Carolina, United States, 28677
- Iredell Memorial Hospital
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Winston-Salem, North Carolina, United States, 27157-1096
- Wake Forest University Comprehensive Cancer Center
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Ohio
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Cleveland, Ohio, United States, 44195
- Cleveland Clinic Taussig Cancer Center
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Cleveland, Ohio, United States, 44106-5065
- Case Comprehensive Cancer Center
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Columbus, Ohio, United States, 43210-1240
- Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center
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Oregon, Ohio, United States, 43616
- St. Charles Mercy Hospital
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Toledo, Ohio, United States, 43623
- Toledo Clinic, Incorporated - Main Clinic
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Pennsylvania
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Danville, Pennsylvania, United States, 17822-0001
- Geisinger Cancer Institute at Geisinger Health
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Philadelphia, Pennsylvania, United States, 19140
- Fox Chase Cancer Center CCOP Research Base
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Wilkes-Barre, Pennsylvania, United States, 18711
- Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center
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South Carolina
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Greenville, South Carolina, United States, 29601
- Bon Secours St. Francis Health System
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Spartanburg, South Carolina, United States, 29303
- CCOP - Upstate Carolina
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Spartanburg, South Carolina, United States, 29303
- Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
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Tennessee
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Jackson, Tennessee, United States, 38301
- West Tennessee Cancer Center at Jackson-Madison County General Hospital
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Nashville, Tennessee, United States, 37232-6838
- Vanderbilt-Ingram Cancer Center
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Texas
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Amarillo, Texas, United States, 79106
- Harrington Cancer Center
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Dallas, Texas, United States, 75390
- Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
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Vermont
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Berlin, Vermont, United States, 05602
- Mountainview Medical
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Burlington, Vermont, United States, 05401
- Fletcher Allen Health Care - University Health Center Campus
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Virginia
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Richmond, Virginia, United States, 23298-0037
- Virginia Commonwealth University Massey Cancer Center
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Washington
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Seattle, Washington, United States, 98195
- University Cancer Center at University of Washington Medical Center
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West Virginia
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Morgantown, West Virginia, United States, 26506
- Mary Babb Randolph Cancer Center at West Virginia University Hospitals
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Wisconsin
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Eau Claire, Wisconsin, United States, 54701
- Center for Cancer Treatment & Prevention at Sacred Heart Hospital
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La Crosse, Wisconsin, United States, 54601
- Gundersen Lutheran Center for Cancer and Blood
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Madison, Wisconsin, United States, 53792-6164
- University of Wisconsin Paul P. Carbone Comprehensive Cancer Center
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Marshfield, Wisconsin, United States, 54449
- Saint Joseph's Hospital
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Marshfield, Wisconsin, United States, 54449
- Marshfield Clinic - Marshfield Center
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Minocqua, Wisconsin, United States, 54548
- Marshfield Clinic - Lakeland Center
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Rhinelander, Wisconsin, United States, 54501
- Ministry Medical Group at Saint Mary's Hospital
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Rice Lake, Wisconsin, United States, 54868
- Marshfield Clinic - Indianhead Center
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Stevens Point, Wisconsin, United States, 54481
- Saint Michael's Hospital Cancer Center
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Weston, Wisconsin, United States, 54476
- Diagnostic and Treatment Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
DISEASE CHARACTERISTICS:
Histologically confirmed* Hodgkin lymphoma
- Clinical stage IA, IB, IIA, or IIB disease according to the modified Ann Arbor Staging Classification system
- Subclassified according to the WHO modification of the Rye Classification
- "E" extension allowed provided all other criteria have been met NOTE: *Pathology materials must be submitted within 60 days of study registration. Core-needle biopsies are acceptable provided they contain adequate tissue for primary diagnosis and immunophenotyping. Fine-needle aspirates not allowed. If multiple specimens are available, submit the most recent.
- No nodular lymphocyte-predominant Hodgkin lymphoma
- No mediastinal mass > 0.33 maximum intrathoracic diameter by standing postero-anterior chest x-ray or peripheral or retroperitoneal adenopathy > 10 cm in its largest diameter
Measurable disease by physical examination or imaging studies
- Any tumor mass measurable in two dimensions and > 1 cm (or 1.5 cm if 0.5 cm slices are used, as in spiral CT scans) allowed
Lesions that are considered intrinsically non-measurable include:
- Bone lesions
- Leptomeningeal disease
- Ascites
- Pleural/pericardial effusion
- Lymphangitis cutis/pulmonis
- Abdominal masses that are not confirmed and followed by imaging techniques
- Cystic lesions
- Lesions that are situated in a previously irradiated area
PATIENT CHARACTERISTICS:
- Performance status 0-2
- ANC ≥ 1,000/μL
- Platelet count ≥ 100,000/μL
- Serum creatinine ≤ 2 mg/dL
- Bilirubin ≤ 2 mg/dL
- AST ≤ 2 times upper limit of normal
- LVEF normal by ECHO or MUGA
- DLCO ≥ 60% with no symptomatic pulmonary disease
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
Patients with known HIV allowed provided they have CD4 counts ≥ 350/mcL
- Patients must not have multi-drug resistant HIV infections (i.e., concurrent AIDS-defining conditions)
- An HIV test is required for patients with a history of IV drug abuse or any behavior associated with an increased risk of HIVinfection
No "currently active" second malignancy other than nonmelanoma skin cancers
- Patients are not considered to have a "currently active" malignancy provided they have completed therapy and are considered by their physician to be at < 30% risk of relapse
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
No prior chemotherapy or radiotherapy for Hodgkin lymphoma
- 1 course of ABVD (doxorubicin, bleomycin, vinblastine, and dacarbazine) allowed and will be considered the first course
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Treatment (chemotherapy and F-18 PET/CT)
See Detailed Description
|
Given IV
Given IV
Given IV
Given IV
Given PO
Undergo FDG PET/CT
Given IV
Given PO
Undergo FDG PET/CT
Given IV
Undergo radiation therapy
Undergo FDG PET/CT
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Progression-Free Survival (PFS) at 36-Months for Patients Who Received 4 Cycles of ABVD
Time Frame: 36 Months
|
The primary objective of this trial is to estimate the 3 year PFS in patients who received 4 cycles of ABVD.
PFS for each patient is measured as the time from registration on trial to the first incident of death or progression.
The PFS at 36 months is calculated as the number of patients who have a progression-free survival time greater than 36 months divided by the total number of patients that started treatment.
For this endpoint, all patients that received 4 cycles of doxorubicin, bleomycin, vinblastine, and dacarbazine (ABVD) are included.
|
36 Months
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36 Month Progression Free Survival Rate of Patients Receiving 4 Cycles of ABVD Versus Patients Receiving 2 Cycles of ABVD and 2 Cycles of BEACOPP and Radiation.
Time Frame: at 36 months
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All patients received an initial 2-28 day cycles of doxorubicin, bleomycin, vinblastine, and dacarbazine (ABVD) on Days 1 and 15.
After the first 2 cycles of ABVD, PET/CT was performed and submitted for central review (cycle 2, days 23-25) and determined whether patients would receive 2 cycles of escalated BEACOPP and involved-field RT (IFRT) or an additional 2 cycles of ABVD.
PFS for each patient is measured as the time from registration on trial to the first incident of death or progression.
The PFS rate at 36 months is calculated as the number of patients who have a progression-free survival time greater than 36 months divided by the total number of patients that started treatment.
For this endpoint, we compare the PFS rate between patients who received 4 cycles of ABVD and patients who received 2 cycles of ABVD and 2 cycles of IFRT.
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at 36 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Complete Response Rate
Time Frame: Up to 5 years
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A Complete Response (CR) was defined as having the following conditions: 1.
A complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy.
2. In patients with a PET scan that was positive before therapy, a post-treatment residual mass of any size is permitted as long as it is PET-negative.
A Complete Response rate was defined as the number of patients who achieved a CR divided by the number of patients that were eligible for analysis in each group.
The CR rate was calculated for patients that completed 4 cycles of ABVD and for patients that completed 2 cycles of ABVD and 2 cycles of BEACOPP and IFRT.
|
Up to 5 years
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: David J. Straus, MD, Memorial Sloan Kettering Cancer Center
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Lymphatic Diseases
- Immunoproliferative Disorders
- Lymphoma
- Hodgkin Disease
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Antineoplastic Agents, Alkylating
- Alkylating Agents
- Myeloablative Agonists
- Antineoplastic Agents, Phytogenic
- Topoisomerase II Inhibitors
- Topoisomerase Inhibitors
- Radiopharmaceuticals
- Antibiotics, Antineoplastic
- Cyclophosphamide
- Etoposide
- Etoposide phosphate
- Fluorodeoxyglucose F18
- Prednisone
- Doxorubicin
- Liposomal doxorubicin
- Dacarbazine
- Bleomycin
- Vinblastine
- Procarbazine
Other Study ID Numbers
- CALGB-50604
- U10CA180821 (U.S. NIH Grant/Contract)
- NCI-2011-02042 (REGISTRY: NCI Clinical Trial Reporting Program)
- CDR0000672913 (REGISTRY: NCI Physician Data Query)
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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