Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002566
Status:
COMPLETED
Last Update Posted:
2021-02-23
First Post:
1999-11-01
Brief Title:
Combination Chemotherapy With Bone Marrow Transplantation in Treating Men With Germ Cell Tumors
Sponsor:
UNICANCER
Organization:
UNICANCER
Study Overview
Official Title:
INTERNATIONAL RANDOMIZED STUDY FOR THE SALVAGE TREATMENT OF GERM CELL TUMOURS
Status:
COMPLETED
Status Verified Date:
2021-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 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
PURPOSE Randomized phase III trial to compare the effectiveness of combination chemotherapy with bone marrow transplantation in treating men with relapsed germ cell tumors
Detailed Description:
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 andor 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 andor 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
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 andor 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-F94-0019 | None | None | None |
| FRE-IT94 | None | None | None |
| FRE-FNCLCC-IT94 | None | None | None |