Combination Chemotherapy With or Without Bone Marrow or Stem Cell Transplantation in Treating Men With Untreated Germ Cell Tumors

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not known whether combining chemotherapy with bone marrow or peripheral stem cell transplantation is more effective than combination chemotherapy alone in treating men with germ cell tumors.

PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy with or without bone marrow or peripheral stem cell transplantation in treating men with previously untreated germ cell tumors.

Conditions

• Childhood Germ Cell Tumor
• Extragonadal Germ Cell Tumor
• Testicular Germ Cell Tumor

Interventions

BIOLOGICAL

bleomycin sulfate

BIOLOGICAL

filgrastim

DRUG

carboplatin

DRUG

cisplatin

DRUG

cyclophosphamide

DRUG

etoposide

PROCEDURE

autologous bone marrow transplantation

PROCEDURE

bone marrow ablation with stem cell support

PROCEDURE

conventional surgery

PROCEDURE

peripheral blood stem cell transplantation

RADIATION

radiation therapy

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• Eastern Cooperative Oncology Group

  collaborator NETWORK

• SWOG Cancer Research Network

  collaborator NETWORK

• Cancer and Leukemia Group B

  collaborator NETWORK

• Memorial Sloan Kettering Cancer Center

  lead OTHER

Principal Investigators

• Robert J. Motzer, MD · Memorial Sloan Kettering Cancer Center

• Patrick J. Loehrer, MD · Indiana University Melvin and Bren Simon Cancer Center

• Kim A. Margolin, MD · City of Hope Comprehensive Cancer Center

• Eric J. Small, MD · University of California, San Francisco

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Eligibility

Min Age

12 Years

Sex

MALE

Healthy Volunteers

No

Timeline & Regulatory

Start

1994-09-30

Completion

2006-07-31

Countries

• United States
• Australia
• Peru
• Puerto Rico

Study Locations