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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

This study has been terminated.
(poor accrual)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00005090
First Posted: August 28, 2003
Last Update Posted: January 24, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
National Cancer Institute (NCI)
Eastern Cooperative Oncology Group
Cancer and Leukemia Group B
Information provided by (Responsible Party):
Southwest Oncology Group
  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: carmustine Drug: cyclophosphamide Drug: dacarbazine Drug: doxorubicin hydrochloride Drug: etoposide Drug: vinblastine Procedure: peripheral blood stem cell transplantation Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Southwest Oncology Group:

Primary Outcome Measures:
  • Progression-free survival [ Time Frame: every 3 months while on protocol treatment, then every 6 months for 2 years, then annually thereafter ]

Secondary Outcome Measures:
  • overall survival [ Time Frame: every 3 months while on treatment, then every 6 months thereafter ]

Enrollment: 11
Study Start Date: April 2000
Study Completion Date: May 2005
Primary Completion Date: May 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 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.
Biological: 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.
Drug: 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.
Drug: 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.
Drug: 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.
Experimental: 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.
Biological: 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.
Drug: carmustine
150/m^2 on days -6 to -4 (4-6 days before transplant).
Other Name: BCNU
Drug: cyclophosphamide
100 mg/kg on day -2 (2 days before transplant).
Drug: 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.
Drug: 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.
Drug: etoposide
60 mg/kg on day -4 (4 days before transplant).
Drug: 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.
Procedure: peripheral blood stem cell transplantation
2 x 10^6 CD34+ blood mononuclear cells/kg of actual body weight

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   15 Years to 65 Years   (Child, Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00005090


  Show 47 Study Locations
Sponsors and Collaborators
Southwest Oncology Group
National Cancer Institute (NCI)
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

Responsible Party: Southwest Oncology Group
ClinicalTrials.gov Identifier: NCT00005090     History of Changes
Other Study ID Numbers: CDR0000067708
S9901 ( Other Identifier: SWOG )
CLB-59802 ( Other Identifier: CALGB )
E-S9901 ( Other Identifier: ECOG )
U10CA032102 ( U.S. NIH Grant/Contract )
First Submitted: April 6, 2000
First Posted: August 28, 2003
Last Update Posted: January 24, 2013
Last Verified: January 2013

Keywords provided by Southwest Oncology Group:
stage III adult Hodgkin lymphoma
stage IV adult Hodgkin lymphoma

Additional relevant MeSH terms:
Hodgkin Disease
Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Cyclophosphamide
Carmustine
Liposomal doxorubicin
Etoposide phosphate
Doxorubicin
Etoposide
Bleomycin
Vinblastine
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Antineoplastic Agents, Phytogenic