Combination Chemotherapy With Bone Marrow Transplantation in Treating Men With Germ Cell Tumors
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|ClinicalTrials.gov Identifier: NCT00002566|
Recruitment Status : Completed
First Posted : January 15, 2004
Last Update Posted : February 23, 2021
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 transplantation is a more effective treatment for men with germ cell tumors.
PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy with bone marrow transplantation in treating men with relapsed germ cell tumors.
|Condition or disease||Intervention/treatment||Phase|
|Extragonadal Germ Cell Tumor Testicular Germ Cell Tumor||Drug: carboplatin Drug: cisplatin Drug: cyclophosphamide Drug: etoposide Drug: ifosfamide Drug: vinblastine sulfate Procedure: autologous bone marrow transplantation Procedure: conventional surgery Procedure: peripheral blood stem cell transplantation||Phase 3|
OBJECTIVES: I. Compare the event-free survival of male patients with germ cell tumors in relapse or first partial remission treated with salvage therapy comprising cisplatin, etoposide, and ifosfamide (PEI) or vinblastine, ifosfamide, and cisplatin (VeIP) with or without high-dose carboplatin, etoposide, and cyclophosphamide, followed by autologous bone marrow and/or peripheral blood stem cell transplantation.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to prior complete remission to first-line treatment (yes vs no), primary site of disease (testicular vs retroperitoneal vs mediastinal), and lung metastases at study entry (yes vs no). Autologous bone marrow and peripheral blood stem cells (PBSC) are harvested. Part I (salvage): Patients are assigned to regimen A if they previously received vinblastine as part of a first-line treatment, such as cisplatin, vinblastine, and bleomycin (PVB) or cisplatin, cyclophosphamide, doxorubicin, vinblastine, and bleomycin (CISCA VB). Patients are assigned to regimen B if they previously received etoposide (VP-16) as part of a first-line treatment, such as bleomycin, VP-16, and cisplatin (BEP). Regimen A: Patients receive cisplatin IV over 2 hours, VP-16 IV over 2 hours, and ifosfamide IV over 1 hour on days 1-5 (PEI). Regimen B: Patients receive cisplatin and etoposide as in regimen A and vinblastine IV on days 1 and 2 (VeIP). Treatment on both regimens continues every 3 weeks for 2 courses. Patients with refractory disease at day 43 are taken off study. Part II: Patients are randomized to 1 of 2 treatment arms. Arm I: Patients receive 2 additional courses of PEI or VeIP. Arm II: Patients receive 1 additional course of PEI or VeIP, followed by 1 course of high-dose carboplatin IV over 2 hours, VP-16 IV over 2 hours, and cyclophosphamide IV over 1 hour on days 1-4. Autologous bone marrow and/or PBSC are reinfused on day 7 of the fourth course for patients on both arms. Patients on both arms with residual disease after the fourth course may undergo surgery.
PROJECTED ACCRUAL: A total of 280 patients will be accrued for this study.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||280 participants|
|Official Title:||INTERNATIONAL RANDOMIZED STUDY FOR THE SALVAGE TREATMENT OF GERM CELL TUMOURS|
|Actual Study Start Date :||February 1994|
|Actual Primary Completion Date :||December 2001|
|Actual Study Completion Date :||December 2003|
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): NCT00002566
|Institut Gustave Roussy|
|Villejuif, France, F-94805|
|Study Chair:||Jose-Louis Pico, MD||Gustave Roussy, Cancer Campus, Grand Paris|