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Combination Chemotherapy With or Without Peripheral Stem Cell Transplantation in Treating Men With Stage III or Stage IV Hodgkin's Disease
This study is ongoing, but not recruiting participants.
First Received: April 6, 2000   Last Updated: April 18, 2009   History of Changes
Sponsors and Collaborators: Southwest Oncology Group
National Cancer Institute (NCI)
Eastern Cooperative Oncology Group
Cancer and Leukemia Group B
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00005090
  Purpose

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.


Condition Intervention Phase
Lymphoma
Biological: bleomycin sulfate
Drug: ABVD regimen
Drug: carmustine
Drug: cyclophosphamide
Drug: dacarbazine
Drug: doxorubicin hydrochloride
Drug: etoposide
Drug: vinblastine
Procedure: peripheral blood stem cell transplantation
Phase III

MedlinePlus related topics: Cancer Hodgkin's Disease Lymphoma
Drug Information available for: Cyclophosphamide Bleomycin Doxorubicin Doxorubicin hydrochloride Etoposide Myocet Vinblastine sulfate Carmustine Vinblastine Dacarbazine Bleomycin sulfate
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized
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

Further study details as provided by National Cancer Institute (NCI):

Study Start Date: April 2000
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

Ages Eligible for Study:   15 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00005090

  Show 47 Study Locations
Sponsors and Collaborators
Southwest Oncology Group
Eastern Cooperative Oncology Group
Cancer and Leukemia Group B
Investigators
Study Chair: 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
  More Information

Additional Information:
No publications provided

Study ID Numbers: CDR0000067708, SWOG-S9901, CLB-59802, E-S9901
Study First Received: April 6, 2000
Last Updated: April 18, 2009
ClinicalTrials.gov Identifier: NCT00005090     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage III adult Hodgkin lymphoma
stage IV adult Hodgkin lymphoma

Study placed in the following topic categories:
Immunoproliferative Disorders
Dacarbazine
Immunologic Factors
Hodgkin Lymphoma, Adult
Carmustine
Hodgkin's Disease
Vinblastine
Antimitotic Agents
Cyclophosphamide
Immunosuppressive Agents
Bleomycin
Etoposide phosphate
Doxorubicin
Anti-Bacterial Agents
Lymphatic Diseases
Tubulin Modulators
Antineoplastic Agents, Alkylating
Antirheumatic Agents
Lymphoproliferative Disorders
Antineoplastic Agents, Phytogenic
Alkylating Agents
Lymphoma
Hodgkin Disease
Etoposide

Additional relevant MeSH terms:
Dacarbazine
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Physiological Effects of Drugs
Vinblastine
Cyclophosphamide
Antibiotics, Antineoplastic
Therapeutic Uses
Lymphoma
Hodgkin Disease
Alkylating Agents
Immunoproliferative Disorders
Neoplasms by Histologic Type
Immune System Diseases
Mitosis Modulators
Carmustine
Antimitotic Agents
Bleomycin
Immunosuppressive Agents
Doxorubicin
Pharmacologic Actions
Lymphatic Diseases
Neoplasms
Tubulin Modulators
Myeloablative Agonists
Antineoplastic Agents, Alkylating
Lymphoproliferative Disorders
Antirheumatic Agents
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on May 07, 2009