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

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

Interventions

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).

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

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• Eastern Cooperative Oncology Group

  collaborator NETWORK

• Cancer and Leukemia Group B

  collaborator NETWORK

• SWOG Cancer Research Network

  lead NETWORK

Principal Investigators

• Ellen R. Gaynor, MD · Loyola University

• Sandra J. Horning, MD · Stanford University

• Linda J. Burns, MD · Masonic Cancer Center, University of Minnesota

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

15 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2000-04-30

Primary Completion

2005-05-31

Completion

2005-05-31

Countries

• United States

Study Locations