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Sponsors and Collaborators: |
Memorial Sloan-Kettering Cancer Center National Cancer Institute (NCI) Eastern Cooperative Oncology Group Southwest Oncology Group Cancer and Leukemia Group B |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00002596 |
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.
Condition | Intervention | Phase |
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Childhood Germ Cell Tumor Extragonadal Germ Cell Tumor Testicular Germ Cell Tumor |
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 |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Active Control |
Official Title: | RANDOMIZED MULTIINSTITUTIONAL PHASE III TRIAL OF BEP AND HIGH DOSE CHEMOTHERAPY VERSUS BEP ALONE IN PREVIOUSLY UNTREATED PATIENTS WITH POOR RISK GERM CELL TUMORS |
Estimated Enrollment: | 270 |
Study Start Date: | September 1994 |
OBJECTIVES:
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center and risk status (poor vs intermediate). Patients are randomized to 1 of 2 treatment arms.
Patients on both arms with brain metastases at presentation undergo radiotherapy and/or surgery concurrently with BEP, if medically indicated.
Patients with normal alpha fetoprotein (AFP) and human chorionic gonadotropin (hCG) tumor marker levels after completion of treatment on arm I or II undergo surgical resection of all residual masses. Patients who have no residual malignant tumor or undergo complete resection of only a mature teratoma receive no further therapy.
Patients on arm I who undergo complete resection of residual malignant tumor receive 2 additional courses of VP-16 and CDDP without bleomycin. Patients on arm II who undergo complete resection of residual malignant tumor receive no additional chemotherapy. Patients with an unresectable residual malignant tumor receive additional therapy at the discretion of the treating physician. Patients with residual tumor marker (AFP and hCG) positivity after treatment on arm I or II undergo resection of residual masses if tumor marker values fall to normal by marker half-life.
PROJECTED ACCRUAL: A total of 270 patients (135 per treatment arm) will be accrued for this study within 4.4 years.
Ages Eligible for Study: | 12 Years and older |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically proven poor-risk, nonseminoma germ cell tumor
Must meet 1 of the following 3 conditions:
Testis or retroperitoneal primary site without visceral metastasis but with any of the following tumor marker values:
Testis or retroperitoneal primary site with 1 or more nonpulmonary visceral metastases (regardless of tumor marker values), including the following:
Histologically proven intermediate-risk, nonseminoma germ cell tumor
Testis or retroperitoneal primary site with no visceral metastasis (except lung), and with any of the following tumor marker values:
Histologically proven intermediate-risk, seminoma germ cell tumor with 1 or more nonpulmonary visceral metastases (regardless of tumor marker values or primary site), including the following:
PATIENT CHARACTERISTICS:
Age:
Sex:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Study Chair: | Robert J. Motzer, MD | Memorial Sloan-Kettering Cancer Center |
Study Chair: | Patrick J. Loehrer, MD | Indiana University Melvin and Bren Simon Cancer Center |
Study Chair: | Kim A. Margolin, MD | Beckman Research Institute |
Study Chair: | Eric J. Small, MD | UCSF Helen Diller Family Comprehensive Cancer Center |
Study ID Numbers: | CDR0000063820, MSKCC-94076, CLB-99812, E-3894, SWOG-9442, NCI-T94-0086D |
Study First Received: | November 1, 1999 |
Last Updated: | April 18, 2009 |
ClinicalTrials.gov Identifier: | NCT00002596 History of Changes |
Health Authority: | United States: Federal Government |
stage II malignant testicular germ cell tumor stage III malignant testicular germ cell tumor testicular seminoma testicular embryonal carcinoma testicular choriocarcinoma testicular teratoma testicular yolk sac tumor testicular embryonal carcinoma and teratoma testicular embryonal carcinoma and teratoma with seminoma testicular embryonal carcinoma and yolk sac tumor testicular embryonal carcinoma and yolk sac tumor with seminoma |
testicular embryonal carcinoma and seminoma testicular yolk sac tumor and teratoma testicular yolk sac tumor and teratoma with seminoma testicular choriocarcinoma and yolk sac tumor testicular choriocarcinoma and embryonal carcinoma testicular choriocarcinoma and teratoma testicular choriocarcinoma and seminoma extragonadal germ cell tumor childhood teratoma childhood malignant testicular germ cell tumor childhood extragonadal germ cell tumor |
Immunologic Factors Testicular Cancer Choriocarcinoma Seminoma Testicular Neoplasms Cyclophosphamide Carboplatin Immunosuppressive Agents Etoposide phosphate Bleomycin |
Carcinoma Anti-Bacterial Agents Cisplatin Neoplasms, Germ Cell and Embryonal Antineoplastic Agents, Alkylating Antirheumatic Agents Alkylating Agents Teratoma Etoposide Extragonadal Germ Cell Tumor |
Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Cyclophosphamide Carboplatin Antibiotics, Antineoplastic Bleomycin |
Immunosuppressive Agents Pharmacologic Actions Neoplasms Neoplasms, Germ Cell and Embryonal Therapeutic Uses Myeloablative Agonists Antineoplastic Agents, Alkylating Antirheumatic Agents Alkylating Agents |