S9901 Combination Chemotherapy With or Without Peripheral Stem Cell Transplantation in Treating Men With Stage III or Stage IV Hodgkin's Disease
NCT ID: NCT00005090
Last Updated: 2013-01-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE3
11 participants
INTERVENTIONAL
2000-04-30
2005-05-31
Brief Summary
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PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy with or without peripheral stem cell transplantation in treating men who have stage III or stage IV Hodgkin's disease.
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Detailed Description
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* Compare progression-free and overall survival of patients with stage III or IV Hodgkin's disease treated with doxorubicin, bleomycin, vinblastine, and dacarbazine with or without autologous peripheral blood stem cell transplantation and high-dose chemotherapy.
* Compare the toxic effects of these treatment regimens in these patients.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to number of poor prognostic factors (3 vs 4 vs 5) and stage of disease (III vs IV).
Patients receive induction chemotherapy consisting of doxorubicin IV over 5 minutes, bleomycin IV over 10 minutes, vinblastine IV over 5 minutes, and dacarbazine IV over 15-30 minutes on days 1 and 15. Treatment repeats every 28 days for 5 courses in the absence of disease progression or unacceptable toxicity. Patients who show at least partial response after the fifth course of induction chemotherapy and whose blood counts have recovered are randomized to 1 of 2 treatment arms.
* Arm I: Patients receive 3 additional courses of induction chemotherapy for a total of 8 courses.
* Arm II: Patients receive 1 additional course of induction chemotherapy followed by stem cell collection. Patients then receive high-dose chemotherapy with carmustine IV over 2 hours on days -6 to -4, etoposide IV over 4 hours on day -4, and cyclophosphamide IV on day -2. Patients undergo autologous peripheral blood stem cell transplantation on day 0.
Patients are followed at 60 days, every 3 months for 1 year, every 6 months for 2 years, and then annually thereafter.
PROJECTED ACCRUAL: Approximately 460 patients will be accrued for this study within 4 years.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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ABVD x 5 + ABVD x 3
Patients receive 5 28-day cycles of ABVD (doxorubicin 25 mg/m\^2, bleomycin 10 U/m\^2, vinblastine 6 mg/m\^2, dacarbazine 375 mg/m\^2 all on days 1 and 15). Patients with no disease progression are then randomized to either 3 more cycles of ABVD or 1 more cycle of ABVD + high-dose therapy + stem cell transplant.
bleomycin sulfate
10 U/m\^2 given on days 1 and 15 for 5 28-day cycles of ABVD. Patients with no disease progression are then randomized to either 3 more cycles of ABVD or 1 more cycle of ABVD + high-dose therapy + stem cell transplant.
dacarbazine
375 mg/m\^2 on days 1 and 15 for 5 28-day cycles of ABVD. Patients with no disease progression are then randomized to either 3 more cycles of ABVD or 1 more cycle of ABVD + high-dose therapy + stem cell transplant.
doxorubicin hydrochloride
25 mg/m\^2 on days 1 and 15 for 5 28-day cycles of ABVD. Patients with no disease progression are then randomized to either 3 more cycles of ABVD or 1 more cycle of ABVD + high-dose therapy + stem cell transplant.
vinblastine
6 mg/m\^2 on days 1 and 15 for 5 28-day cycles of ABVD. Patients with no disease progression are then randomized to either 3 more cycles of ABVD or 1 more cycle of ABVD + high-dose therapy + stem cell transplant.
ABVD x 5 + ABVD x 1 + HDT + PBSCT
Patients receive 5 28-day cycles of ABVD (doxorubicin 25 mg/m\^2, bleomycin 10 U/m\^2, vinblastine 6 mg/m\^2, dacarbazine 375 mg/m\^2 all on days 1 and 15). Patients with no disease progression are then randomized to either 3 more cycles of ABVD or 1 more cycle of ABVD + high-dose therapy + stem cell transplant. Patients randomized to the transplant arm have 2 x 10\^6 CD34+ blood mononuclear cells/kg of actual body weight collected at day -7. High dose therapy consists of BCNU 150/m\^2 on days -6 to -4, etoposide 60 mg/kg on day -4, and cyclophosphamide 100 mg/kg on day -2. Peripheral blood stem cells are infused on day 0.
bleomycin sulfate
10 U/m\^2 given on days 1 and 15 for 5 28-day cycles of ABVD. Patients with no disease progression are then randomized to either 3 more cycles of ABVD or 1 more cycle of ABVD + high-dose therapy + stem cell transplant.
carmustine
150/m\^2 on days -6 to -4 (4-6 days before transplant).
cyclophosphamide
100 mg/kg on day -2 (2 days before transplant).
dacarbazine
375 mg/m\^2 on days 1 and 15 for 5 28-day cycles of ABVD. Patients with no disease progression are then randomized to either 3 more cycles of ABVD or 1 more cycle of ABVD + high-dose therapy + stem cell transplant.
doxorubicin hydrochloride
25 mg/m\^2 on days 1 and 15 for 5 28-day cycles of ABVD. Patients with no disease progression are then randomized to either 3 more cycles of ABVD or 1 more cycle of ABVD + high-dose therapy + stem cell transplant.
etoposide
60 mg/kg on day -4 (4 days before transplant).
vinblastine
6 mg/m\^2 on days 1 and 15 for 5 28-day cycles of ABVD. Patients with no disease progression are then randomized to either 3 more cycles of ABVD or 1 more cycle of ABVD + high-dose therapy + stem cell transplant.
peripheral blood stem cell transplantation
2 x 10\^6 CD34+ blood mononuclear cells/kg of actual body weight
Interventions
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bleomycin sulfate
10 U/m\^2 given on days 1 and 15 for 5 28-day cycles of ABVD. Patients with no disease progression are then randomized to either 3 more cycles of ABVD or 1 more cycle of ABVD + high-dose therapy + stem cell transplant.
carmustine
150/m\^2 on days -6 to -4 (4-6 days before transplant).
cyclophosphamide
100 mg/kg on day -2 (2 days before transplant).
dacarbazine
375 mg/m\^2 on days 1 and 15 for 5 28-day cycles of ABVD. Patients with no disease progression are then randomized to either 3 more cycles of ABVD or 1 more cycle of ABVD + high-dose therapy + stem cell transplant.
doxorubicin hydrochloride
25 mg/m\^2 on days 1 and 15 for 5 28-day cycles of ABVD. Patients with no disease progression are then randomized to either 3 more cycles of ABVD or 1 more cycle of ABVD + high-dose therapy + stem cell transplant.
etoposide
60 mg/kg on day -4 (4 days before transplant).
vinblastine
6 mg/m\^2 on days 1 and 15 for 5 28-day cycles of ABVD. Patients with no disease progression are then randomized to either 3 more cycles of ABVD or 1 more cycle of ABVD + high-dose therapy + stem cell transplant.
peripheral blood stem cell transplantation
2 x 10\^6 CD34+ blood mononuclear cells/kg of actual body weight
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Histologically confirmed stage III or IV Hodgkin's disease with at least 3 of the following characteristics:
* Albumin less than 4.0 mg/dL
* Hemoglobin less than 10.5 g/dL
* Leukocytosis at least 15,000/mm\^3
* Lymphocytopenia less than 600/mm\^3 or less than 8% of total WBC
* Male sex
* At least 45 years of age
* Stage IV disease
* Bidimensionally measurable disease
* Bilateral or unilateral bone marrow aspiration and biopsy performed within 42 days of study
* Negative chest x-ray within 42 days of study OR
* Chest x-ray performed within 28 days of study
* Negative CT scan of thorax, abdomen, and pelvis within 42 days of study OR
* CT scan of thorax, abdomen, and pelvis performed within 28 days of study
* No history of lymphoma, myelodyplastic syndrome, or leukemia
* No CNS involvement by Hodgkin's disease
PATIENT CHARACTERISTICS:
Age:
* 15 to 65
Performance status:
* Zubrod 0-1
Life expectancy:
* Not specified
Hematopoietic:
* See Disease Characteristics
Hepatic:
* See Disease Characteristics
* Bilirubin no greater than 1.5 times upper limit of normal (ULN) (unless elevation due to liver infiltration by Hodgkin's disease)
* Lymphoma-related hepatic dysfunction allowed
Renal:
* Creatinine no greater than 2.0 times ULN
* Creatinine clearance at least 60 mL/min
* Lymphoma-related renal dysfunction allowed
Cardiovascular:
* No coronary artery disease, cardiomyopathy, congestive heart failure, or arrhythmias requiring therapy
* Ejection fraction normal
* No significant EKG abnormalities suggesting active cardiac disease
Pulmonary:
* Corrected DLCO at least 60% OR
* FEV1 at least 60% predicted
Other:
* Not pregnant or nursing
* Fertile patients must use effective contraception
* No HIV or AIDS
* No other prior malignancy within past 5 years except adequately treated basal cell or squamous cell skin cancer
* No active bacterial, fungal, or viral infection\*
* Afebrile for 3 consecutive days\* NOTE: \*Prior to randomization portion of study
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* Not specified
Chemotherapy:
* No prior chemotherapy for Hodgkin's disease except single course of ABVD (doxorubicin, bleomycin, vinblastine, and dacarbazine) within 35 days of study
Endocrine therapy:
* Not specified
Radiotherapy:
* No prior radiotherapy for Hodgkin's disease
Surgery:
* Not specified
Other:
* At least 3 days since prior antibiotics, antifungals, or antivirals (except for prophylactic therapy or fever associated with underlying lymphoma) (for randomization portion of study)
15 Years
65 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Eastern Cooperative Oncology Group
NETWORK
Cancer and Leukemia Group B
NETWORK
SWOG Cancer Research Network
NETWORK
Responsible Party
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Principal Investigators
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Ellen R. Gaynor, MD
Role: STUDY_CHAIR
Loyola University
Sandra J. Horning, MD
Role: STUDY_CHAIR
Stanford University
Linda J. Burns, MD
Role: STUDY_CHAIR
Masonic Cancer Center, University of Minnesota
Locations
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Veterans Affairs Medical Center - Birmingham
Birmingham, Alabama, United States
University of California San Diego Cancer Center
La Jolla, California, United States
Veterans Affairs Medical Center - San Francisco
San Francisco, California, United States
UCSF Cancer Center and Cancer Research Institute
San Francisco, California, United States
CCOP - Christiana Care Health Services
Wilmington, Delaware, United States
Lombardi Cancer Center
Washington D.C., District of Columbia, United States
Walter Reed Army Medical Center
Washington D.C., District of Columbia, United States
CCOP - Mount Sinai Medical Center
Miami Beach, Florida, United States
Veterans Affairs Medical Center - Chicago (Westside Hospital)
Chicago, Illinois, United States
University of Chicago Cancer Research Center
Chicago, Illinois, United States
Holden Comprehensive Cancer Center at The University of Iowa
Iowa City, Iowa, United States
Veterans Affairs Medical Center - Togus
Togus, Maine, United States
Marlene & Stewart Greenebaum Cancer Center, University of Maryland
Baltimore, Maryland, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
University of Massachusetts Memorial Medical Center
Worcester, Massachusetts, United States
Veterans Affairs Medical Center - Minneapolis
Minneapolis, Minnesota, United States
University of Minnesota Cancer Center
Minneapolis, Minnesota, United States
Veterans Affairs Medical Center - Columbia (Truman Memorial)
Columbia, Missouri, United States
Ellis Fischel Cancer Center - Columbia
Columbia, Missouri, United States
Barnes-Jewish Hospital
St Louis, Missouri, United States
University of Nebraska Medical Center
Omaha, Nebraska, United States
CCOP - Southern Nevada Cancer Research Foundation
Las Vegas, Nevada, United States
Norris Cotton Cancer Center
Lebanon, New Hampshire, United States
Veterans Affairs Medical Center - Buffalo
Buffalo, New York, United States
Roswell Park Cancer Institute
Buffalo, New York, United States
CCOP - North Shore University Hospital
Manhasset, New York, United States
Schneider Children's Hospital at North Shore
Manhasset, New York, United States
Memorial Sloan-Kettering Cancer Center
New York, New York, United States
New York Presbyterian Hospital - Cornell Campus
New York, New York, United States
Mount Sinai Medical Center, NY
New York, New York, United States
State University of New York - Upstate Medical University
Syracuse, New York, United States
Veterans Affairs Medical Center - Syracuse
Syracuse, New York, United States
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
Syracuse, New York, United States
Lineberger Comprehensive Cancer Center, UNC
Chapel Hill, North Carolina, United States
Veterans Affairs Medical Center - Durham
Durham, North Carolina, United States
Duke Comprehensive Cancer Center
Durham, North Carolina, United States
CCOP - Southeast Cancer Control Consortium
Winston-Salem, North Carolina, United States
Comprehensive Cancer Center at Wake Forest University
Winston-Salem, North Carolina, United States
Arthur G. James Cancer Hospital - Ohio State University
Columbus, Ohio, United States
Rhode Island Hospital
Providence, Rhode Island, United States
University of Tennessee, Memphis Cancer Center
Memphis, Tennessee, United States
Veterans Affairs Medical Center - Memphis
Memphis, Tennessee, United States
Green Mountain Oncology Group
Bennington, Vermont, United States
Vermont Cancer Center
Burlington, Vermont, United States
Veterans Affairs Medical Center - White River Junction
White River Junction, Vermont, United States
Veterans Affairs Medical Center - Richmond
Richmond, Virginia, United States
MBCCOP - Massey Cancer Center
Richmond, Virginia, United States
Countries
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Other Identifiers
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S9901
Identifier Type: OTHER
Identifier Source: secondary_id
CLB-59802
Identifier Type: OTHER
Identifier Source: secondary_id
E-S9901
Identifier Type: OTHER
Identifier Source: secondary_id
CDR0000067708
Identifier Type: -
Identifier Source: org_study_id
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