Combination Chemotherapy in Treating Patients With Newly Diagnosed Stage I or Stage II Hodgkin's Lymphoma

June 30, 2016 updated by: Alliance for Clinical Trials in Oncology

Phase II Trial of Doxorubicin, Vinblastine, and Gemcitabine (AVG) Chemotherapy for Non-Bulky Stage I and II Hodgkin's Lymphoma

RATIONALE: Drugs used in chemotherapy, such as doxorubicin, vinblastine, and gemcitabine, work in different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells.

PURPOSE: This phase II trial is studying how well combination chemotherapy works in treating patients with newly diagnosed stage I or stage II Hodgkin's lymphoma.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

Primary

  • Determine the complete response rate in patients with newly diagnosed stage IA, IB, IIA, or IIB non-bulky Hodgkin's lymphoma treated with doxorubicin, vinblastine, and gemcitabine.

Secondary

  • Determine the event-free survival of patients treated with this regimen.
  • Determine the toxicity of this regimen in these patients.
  • Determine whether fludeoxyglucose F 18 positron-emission tomography scanning is useful in predicting clinical relapse and determining the presence of residual disease in these patients after treatment with this regimen.

OUTLINE: This is a multicenter study.

Patients receive doxorubicin IV over 3-5 minutes, vinblastine IV over 3-5 minutes, and gemcitabine IV over 30 minutes on days 1 and 15. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.

Patients undergo fludeoxyglucose F 18 positron-emission tomography (PET) scanning and CT scan before treatment and after courses 2 and 6 of therapy to assess response. Patients with a positive PET scan after completion of study therapy may undergo biopsy. A PET scan is performed 3 months later if biopsy is negative or biopsy is unable to be performed.

Patients are followed every 3 months for 1 year, every 4 months for 2 years, every 6 months for 2 years, and then annually for 5 years.

Study Type

Interventional

Enrollment (Actual)

104

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
    • California
      • San Francisco, California, United States, 94115
        • UCSF Comprehensive Cancer Center
    • Delaware
      • Lewes, Delaware, United States, 19958
        • 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
      • Washington, District of Columbia, United States, 20307-5001
        • Walter Reed Army Medical Center
    • Illinois
      • Chicago, Illinois, United States, 60637-1470
        • University of Chicago Cancer Research Center
    • Indiana
      • Elkhart, Indiana, United States, 46515
        • Elkhart General Hospital
      • Kokomo, Indiana, United States, 46904
        • Howard Community Hospital at Howard Regional Health System
      • La Porte, Indiana, United States, 46350
        • Center for Cancer Therapy at LaPorte Hospital and Health Services
      • South Bend, Indiana, United States, 46601
        • Memorial Hospital of South Bend
      • South Bend, Indiana, United States, 46601
        • CCOP - Northern Indiana CR Consortium
      • South Bend, Indiana, United States, 46617
        • Saint Joseph Regional Medical Center
    • Iowa
      • Cedar Rapids, Iowa, United States, 52402
        • St. Luke's Hospital
      • Cedar Rapids, Iowa, United States, 52403
        • Mercy Regional Cancer Center at Mercy Medical Center
      • Cedar Rapids, Iowa, United States, 52402
        • Iowa Blood and Cancer Care
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • Greenebaum Cancer Center at University of Maryland Medical Center
      • Elkton MD, Maryland, United States, 21921
        • Union Hospital Cancer Center at Union Hospital
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital Cancer Center
      • Boston, Massachusetts, United States, 02115
        • Dana-Farber/Brigham and Women's Cancer Center
    • Michigan
      • St. Joseph, Michigan, United States, 49085
        • Lakeland Cancer Care Center at Lakeland Hospital - St. Joseph
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • University of Minnesota Medical Center - Fairview
    • Missouri
      • Columbia, Missouri, United States, 65201
        • Missouri Cancer Associates
      • St Louis, Missouri, United States, 63110
        • Siteman Cancer Center at Barnes-Jewish Hospital
    • Nebraska
      • Grand Island, Nebraska, United States, 68803
        • Saint Francis Cancer Treatment Center at Saint Francis Memorial Health Center
      • North Platte, Nebraska, United States, 69101-6598
        • Great Plains Regional Medical Center
      • Omaha, Nebraska, United States, 68198-6805
        • UNMC Eppley Cancer Center at the University of Nebraska Medical Center
    • New Jersey
      • Voorhees, New Jersey, United States, 08043
        • Cancer Institute of New Jersey at Cooper - Voorhees
    • New York
      • Buffalo, New York, United States, 14263-0001
        • Roswell Park Cancer Institute
      • Glens Falls, New York, United States, 12801
        • Charles R. Wood Cancer Center at Glens Falls Hospital
      • New York, New York, United States, 10021
        • Memorial Sloan-Kettering Cancer Center
      • New York, New York, United States, 10021
        • New York Weill Cornell Cancer Center at Cornell University
      • Syracuse, New York, United States, 13210
        • SUNY Upstate Medical University Hospital
      • Syracuse, New York, United States, 13057
        • CCOP - Hematology-Oncology Associates of Central New York
      • Syracuse, New York, United States, 13215
        • Community General Hospital
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599-7295
        • Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
      • Charlotte, North Carolina, United States, 28233-3549
        • Presbyterian Cancer Center at Presbyterian Hospital
      • Goldsboro, North Carolina, United States, 27534
        • Wayne Radiation Oncology
      • Goldsboro, North Carolina, United States, 27534
        • Wayne Memorial Hospital, Incorporated
      • Kinston, North Carolina, United States, 28501
        • Lenoir Memorial Cancer Center
      • Wilson, North Carolina, United States, 27893-3428
        • Wilson Medical Center
      • Winston-Salem, North Carolina, United States, 27157-1096
        • Wake Forest University Comprehensive Cancer Center
    • Ohio
      • Columbus, Ohio, United States, 43210-1240
        • Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University
    • South Carolina
      • Greenville, South Carolina, United States, 29615
        • CCOP - Greenville
      • Greenville, South Carolina, United States, 29601
        • Bon Secours St. Francis Health System
    • Vermont
      • Berlin, Vermont, United States, 05602
        • Mountainview Medical
      • Burlington, Vermont, United States, 05401
        • Fletcher Allen Health Care - University Health Center Campus

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

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

  1. Documentation of Disease:

    1.1 Histologically documented Hodgkin lymphoma subclassified according to the WHO modification of the Rye Classification and staged according to the modified Ann Arbor Staging Classification system. Patients must have clinical stage IA, IB, IIA or IIB. Patients with "E" extensions will be eligible if all other criteria have been met. Nodular lymphocyte predominant Hodgkin lymphoma is excluded.

    • Core biopsies are acceptable if they contain adequate tissue for primary diagnosis and immunophenotyping. Fine needle aspirate (FNA) cytologies and bone marrow biopsies as the sole means of diagnosis are not acceptable.
    • Note: Failure to submit pathology slides within 60 days of patient registration will result in patient being declared ineligible.

    1.2 Patients may not have a mediastinal mass > 0.33 maximum intrathoracic diameter on standing postero-anterior chest x-ray or peripheral or retroperitoneal adenopathy > 10 cm in its largest diameter.

    1.3 Bone marrow biopsy is required for pretreatment evaluation. Bilateral biopsies are preferred but not required.

  2. No prior treatment (chemotherapy or radiation therapy) for Hodgkin lymphoma.

  3. Measurable disease must be present either on physical examination or imaging studies. Any tumor mass measurable in two dimensions and > 2 cm is acceptable (or 1.5 cm if 0.5 cm slices are used as in spiral CT scans). Lesions that are considered intrinsically non-measurable include the following:

    • bone lesions
    • leptomeningeal disease
    • ascites
    • pleural/pericardial effusion
    • inflammatory breast disease
    • 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
  4. Age ≥ 16 years
  5. Performance status 0-2
  6. LVEF by ECHO or MUGA within institutional normal limits
  7. DLCO ≥ 60% with no symptomatic pulmonary disease
  8. No known HIV infection. Patients with a history of intravenous drug abuse or any behavior associated with an increased risk of HIV infection should be tested for exposure to the HIV virus. Patients who test positive or who are known to be infected are not eligible due to an increased risk of infection with this chemotherapy regimen. An HIV test is not required for entry on this protocol, but is required if the patient is perceived to be at risk.
  9. Non-pregnant and non-lactating. Due to the teratogenic potential of the agents used in this study, pregnant or nursing women may not be enrolled. Women and men of reproductive potential should agree to use an effective means of birth control.

  10. Initial Required Laboratory Data:

    • ANC ≥ 1000/μL
    • Platelet count ≥ 100,000/μL
    • Serum Creatinine ≤ 2 mg/dL
    • Bilirubin ≤ 2 mg/dL
    • AST ≤ 2 x upper limit of normal

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: doxorubicin + vinblastine + gemcitabine

Patients receive doxorubicin IV over 3-5 minutes, vinblastine IV over 3-5 minutes, and gemcitabine IV over 30 minutes on days 1 and 15. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.

Patients undergo fludeoxyglucose F 18 positron-emission tomography (PET) scanning and CT scan before treatment and after courses 2 and 6 of therapy to assess response. Patients with a positive PET scan after completion of study therapy may undergo biopsy. A PET scan is performed 3 months later if biopsy is negative or biopsy is unable to be performed.

Patients are followed every 3 months for 1 year, every 4 months for 2 years, every 6 months for 2 years, and then annually for 5 years.
Procedure: CT scan
Drug: gemcitabine hydrochloride
given IV
Drug: vinblastine
given IV
Drug: doxorubicin hydrochloride
given IV
Procedure: fludeoxyglucose F 18 positron-emission tomography (PET) scan

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Response
Time Frame: 24 weeks
24 weeks

Collaborators and Investigators

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

Sponsor

Alliance for Clinical Trials in Oncology

Collaborators

National Cancer Institute (NCI)

Investigators

  • Study Chair: David Straus, MD, Memorial Sloan Kettering 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

May 1, 2004

Primary Completion (Actual)

March 1, 2007

Study Completion (Actual)

May 1, 2011

Study Registration Dates

First Submitted

July 8, 2004

First Submitted That Met QC Criteria

July 9, 2004

First Posted (Estimate)

July 12, 2004

Study Record Updates

Last Update Posted (Estimate)

July 1, 2016

Last Update Submitted That Met QC Criteria

June 30, 2016

Last Verified

June 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CALGB-50203
  • U10CA031946 (U.S. NIH Grant/Contract)
  • CDR0000370870 (Registry Identifier: 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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