S9901 Combination Chemotherapy With or Without Peripheral Stem Cell Transplantation in Treating Men With Stage III or Stage IV Hodgkin's Disease

NCT00005090 | Terminated Phase 3 DMC

• 5 other identifiers: CDR0000067708S9901CLB-59802E-S9901U10CA032102
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 47

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells. It is not yet known if combination chemotherapy is more effective with or without peripheral stem cell transplantation in treating Hodgkin's Disease. 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.

Conditions

Lymphoma

Keywords

stage III adult Hodgkin lymphoma; stage IV adult Hodgkin lymphoma

Outcome Measures

Primary Outcomes (1)

• Progression-free survival

  every 3 months while on protocol treatment, then every 6 months for 2 years, then annually thereafter

Secondary Outcomes (1)

• overall survival

  every 3 months while on treatment, then every 6 months thereafter

Study Arms (2)

ABVD x 5 + ABVD x 3

ACTIVE COMPARATOR

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.

Biological: bleomycin sulfate; Drug: dacarbazine; Drug: doxorubicin hydrochloride; Drug: vinblastine

ABVD x 5 + ABVD x 1 + HDT + PBSCT

EXPERIMENTAL

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.

Biological: bleomycin sulfate; Drug: carmustine; Drug: cyclophosphamide; Drug: dacarbazine; Drug: doxorubicin hydrochloride; Drug: etoposide; Drug: vinblastine; Procedure: peripheral blood stem cell transplantation

Interventions

bleomycin sulfate BIOLOGICAL

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.

ABVD x 5 + ABVD x 1 + HDT + PBSCT; ABVD x 5 + ABVD x 3

carmustine DRUG

150/m\^2 on days -6 to -4 (4-6 days before transplant).

Also known as: BCNU

ABVD x 5 + ABVD x 1 + HDT + PBSCT

cyclophosphamide DRUG

100 mg/kg on day -2 (2 days before transplant).

ABVD x 5 + ABVD x 1 + HDT + PBSCT

dacarbazine DRUG

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.

ABVD x 5 + ABVD x 1 + HDT + PBSCT; ABVD x 5 + ABVD x 3

doxorubicin hydrochloride DRUG

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.

ABVD x 5 + ABVD x 1 + HDT + PBSCT; ABVD x 5 + ABVD x 3

etoposide DRUG

60 mg/kg on day -4 (4 days before transplant).

ABVD x 5 + ABVD x 1 + HDT + PBSCT

vinblastine DRUG

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; ABVD x 5 + ABVD x 3

peripheral blood stem cell transplantation PROCEDURE

2 x 10\^6 CD34+ blood mononuclear cells/kg of actual body weight

ABVD x 5 + ABVD x 1 + HDT + PBSCT

Eligibility Criteria

• Age: 15 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * 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)

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• SWOG Cancer Research Network: lead
• National Cancer Institute (NCI): collaborator
• Eastern Cooperative Oncology Group: collaborator
• Cancer and Leukemia Group B: collaborator

Study Sites (47)

Veterans Affairs Medical Center - Birmingham

Birmingham, Alabama, 35233-1996, United States

Location

University of California San Diego Cancer Center

La Jolla, California, 92093-0658, United States

Location

Veterans Affairs Medical Center - San Francisco

San Francisco, California, 94121, United States

Location

UCSF Cancer Center and Cancer Research Institute

San Francisco, California, 94143-0128, United States

Location

CCOP - Christiana Care Health Services

Wilmington, Delaware, 19899, United States

Location

Lombardi Cancer Center

Washington D.C., District of Columbia, 20007, United States

Location

Walter Reed Army Medical Center

Washington D.C., District of Columbia, 20307-5000, United States

Location

CCOP - Mount Sinai Medical Center

Miami Beach, Florida, 33140, United States

Location

Veterans Affairs Medical Center - Chicago (Westside Hospital)

Chicago, Illinois, 60612, United States

Location

University of Chicago Cancer Research Center

Chicago, Illinois, 60637-1470, United States

Location

Holden Comprehensive Cancer Center at The University of Iowa

Iowa City, Iowa, 52242-1009, United States

Location

Veterans Affairs Medical Center - Togus

Togus, Maine, 04330, United States

Location

Marlene & Stewart Greenebaum Cancer Center, University of Maryland

Baltimore, Maryland, 21201, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

University of Massachusetts Memorial Medical Center

Worcester, Massachusetts, 01655, United States

Location

Veterans Affairs Medical Center - Minneapolis

Minneapolis, Minnesota, 55417, United States

Location

University of Minnesota Cancer Center

Minneapolis, Minnesota, 55455, United States

Location

Veterans Affairs Medical Center - Columbia (Truman Memorial)

Columbia, Missouri, 65201, United States

Location

Ellis Fischel Cancer Center - Columbia

Columbia, Missouri, 65203, United States

Location

Barnes-Jewish Hospital

St Louis, Missouri, 63110, United States

Location

University of Nebraska Medical Center

Omaha, Nebraska, 68198-3330, United States

Location

CCOP - Southern Nevada Cancer Research Foundation

Las Vegas, Nevada, 89106, United States

Location

Norris Cotton Cancer Center

Lebanon, New Hampshire, 03756-0002, United States

Location

Veterans Affairs Medical Center - Buffalo

Buffalo, New York, 14215, United States

Location

Roswell Park Cancer Institute

Buffalo, New York, 14263-0001, United States

Location

CCOP - North Shore University Hospital

Manhasset, New York, 11030, United States

Location

Schneider Children's Hospital at North Shore

Manhasset, New York, 11030, United States

Location

Memorial Sloan-Kettering Cancer Center

New York, New York, 10021, United States

Location

New York Presbyterian Hospital - Cornell Campus

New York, New York, 10021, United States

Location

Mount Sinai Medical Center, NY

New York, New York, 10029, United States

Location

State University of New York - Upstate Medical University

Syracuse, New York, 13210, United States

Location

Veterans Affairs Medical Center - Syracuse

Syracuse, New York, 13210, United States

Location

CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.

Syracuse, New York, 13217, United States

Location

Lineberger Comprehensive Cancer Center, UNC

Chapel Hill, North Carolina, 27599-7295, United States

Location

Veterans Affairs Medical Center - Durham

Durham, North Carolina, 27705, United States

Location

Duke Comprehensive Cancer Center

Durham, North Carolina, 27710, United States

Location

CCOP - Southeast Cancer Control Consortium

Winston-Salem, North Carolina, 27104-4241, United States

Location

Comprehensive Cancer Center at Wake Forest University

Winston-Salem, North Carolina, 27157-1082, United States

Location

Arthur G. James Cancer Hospital - Ohio State University

Columbus, Ohio, 43210-1240, United States

Location

Rhode Island Hospital

Providence, Rhode Island, 02903, United States

Location

University of Tennessee, Memphis Cancer Center

Memphis, Tennessee, 38103, United States

Location

Veterans Affairs Medical Center - Memphis

Memphis, Tennessee, 38104, United States

Location

Green Mountain Oncology Group

Bennington, Vermont, 05201, United States

Location

Vermont Cancer Center

Burlington, Vermont, 05401-3498, United States

Location

Veterans Affairs Medical Center - White River Junction

White River Junction, Vermont, 05009, United States

Location

Veterans Affairs Medical Center - Richmond

Richmond, Virginia, 23249, United States

Location

MBCCOP - Massey Cancer Center

Richmond, Virginia, 23298-0037, United States

Location

MeSH Terms

Conditions

Lymphoma; Hodgkin Disease

Interventions

Bleomycin; Carmustine; Cyclophosphamide; Dacarbazine; Doxorubicin; Etoposide; Vinblastine; Peripheral Blood Stem Cell Transplantation

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Glycopeptides; Glycoconjugates; Carbohydrates; Peptides; Amino Acids, Peptides, and Proteins; Nitrosourea Compounds; Urea; Amides; Organic Chemicals; Nitroso Compounds; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Phosphoramides; Organophosphorus Compounds; Triazenes; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Polycyclic Compounds; Aminoglycosides; Glycosides; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Glucosides; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines; Hematopoietic Stem Cell Transplantation; Stem Cell Transplantation; Cell Transplantation; Cell- and Tissue-Based Therapy; Biological Therapy; Therapeutics; Transplantation; Surgical Procedures, Operative

Study Officials

• Ellen R. Gaynor, MD

  Loyola University

  STUDY CHAIR

• Sandra J. Horning, MD

  Stanford University

  STUDY CHAIR

• Linda J. Burns, MD

  Masonic Cancer Center, University of Minnesota

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 6, 2000
• First Posted: August 28, 2003
• Study Start: April 1, 2000
• Primary Completion: May 1, 2005
• Study Completion: May 1, 2005
• Last Updated: January 24, 2013

Record last verified: 2013-01

Locations

US (47)