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

Information source: Southwest Oncology Group
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Lymphoma

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

Phase: Phase 3

Status: Terminated

Sponsored by: Southwest Oncology Group

Official(s) and/or principal investigator(s):
Ellen R. Gaynor, MD, Study Chair, Affiliation: Loyola University
Sandra J. Horning, MD, Study Chair, Affiliation: Stanford University
Linda J. Burns, MD, Study Chair, Affiliation: Masonic Cancer Center, University of Minnesota

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.

Clinical Details

Official title: A Randomized Phase III Trial Comparing Early High Dose Chemotherapy and an Autologous Stem Cell Transplant to Conventional Dose ABVD Chemotherapy for Patients With Advanced Stage Poor Prognosis Hodgkin's Disease as Defined by the International Prognostic Factors Project on Advanced Hodgkin's Disease

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Progression-free survival

Secondary outcome: overall survival

Detailed description: OBJECTIVES:

- 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.

Eligibility

Minimum age: 15 Years. Maximum age: 65 Years. Gender(s): Both.

Criteria:

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)

Locations and Contacts

Veterans Affairs Medical Center - Birmingham, Birmingham, Alabama 35233-1996, United States

University of California San Diego Cancer Center, La Jolla, California 92093-0658, United States

UCSF Cancer Center and Cancer Research Institute, San Francisco, California 94143-0128, United States

Veterans Affairs Medical Center - San Francisco, San Francisco, California 94121, United States

CCOP - Christiana Care Health Services, Wilmington, Delaware 19899, United States

Lombardi Cancer Center, Washington, District of Columbia 20007, United States

Walter Reed Army Medical Center, Washington, District of Columbia 20307-5000, United States

CCOP - Mount Sinai Medical Center, Miami Beach, Florida 33140, United States

University of Chicago Cancer Research Center, Chicago, Illinois 60637-1470, United States

Veterans Affairs Medical Center - Chicago (Westside Hospital), Chicago, Illinois 60612, United States

Holden Comprehensive Cancer Center at The University of Iowa, Iowa City, Iowa 52242-1009, United States

Veterans Affairs Medical Center - Togus, Togus, Maine 04330, United States

Marlene & Stewart Greenebaum Cancer Center, University of Maryland, Baltimore, Maryland 21201, United States

Dana-Farber Cancer Institute, Boston, Massachusetts 02115, United States

University of Massachusetts Memorial Medical Center, Worcester, Massachusetts 01655, United States

University of Minnesota Cancer Center, Minneapolis, Minnesota 55455, United States

Veterans Affairs Medical Center - Minneapolis, Minneapolis, Minnesota 55417, United States

Ellis Fischel Cancer Center - Columbia, Columbia, Missouri 65203, United States

Veterans Affairs Medical Center - Columbia (Truman Memorial), Columbia, Missouri 65201, United States

Barnes-Jewish Hospital, Saint Louis, Missouri 63110, United States

University of Nebraska Medical Center, Omaha, Nebraska 68198-3330, United States

CCOP - Southern Nevada Cancer Research Foundation, Las Vegas, Nevada 89106, United States

Norris Cotton Cancer Center, Lebanon, New Hampshire 03756-0002, United States

Roswell Park Cancer Institute, Buffalo, New York 14263-0001, United States

Veterans Affairs Medical Center - Buffalo, Buffalo, New York 14215, United States

CCOP - North Shore University Hospital, Manhasset, New York 11030, United States

Schneider Children's Hospital at North Shore, Manhasset, New York 11030, United States

Memorial Sloan-Kettering Cancer Center, New York, New York 10021, United States

Mount Sinai Medical Center, NY, New York, New York 10029, United States

New York Presbyterian Hospital - Cornell Campus, New York, New York 10021, United States

CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C., Syracuse, New York 13217, United States

State University of New York - Upstate Medical University, Syracuse, New York 13210, United States

Veterans Affairs Medical Center - Syracuse, Syracuse, New York 13210, United States

Lineberger Comprehensive Cancer Center, UNC, Chapel Hill, North Carolina 27599-7295, United States

Duke Comprehensive Cancer Center, Durham, North Carolina 27710, United States

Veterans Affairs Medical Center - Durham, Durham, North Carolina 27705, United States

CCOP - Southeast Cancer Control Consortium, Winston-Salem, North Carolina 27104-4241, United States

Comprehensive Cancer Center at Wake Forest University, Winston-Salem, North Carolina 27157-1082, United States

Arthur G. James Cancer Hospital - Ohio State University, Columbus, Ohio 43210-1240, United States

Rhode Island Hospital, Providence, Rhode Island 02903, United States

University of Tennessee, Memphis Cancer Center, Memphis, Tennessee 38103, United States

Veterans Affairs Medical Center - Memphis, Memphis, Tennessee 38104, United States

Green Mountain Oncology Group, Bennington, Vermont 05201, United States

Vermont Cancer Center, Burlington, Vermont 05401-3498, United States

Veterans Affairs Medical Center - White River Junction, White River Junction, Vermont 05009, United States

MBCCOP - Massey Cancer Center, Richmond, Virginia 23298-0037, United States

Veterans Affairs Medical Center - Richmond, Richmond, Virginia 23249, United States

Additional Information

Starting date: April 2000
Last updated: January 22, 2013

Page last updated: August 23, 2015

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