Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002596
Status:
COMPLETED
Last Update Posted:
2013-06-26
First Post:
1999-11-01
Brief Title:
Combination Chemotherapy With or Without Bone Marrow or Stem Cell Transplantation in Treating Men With Untreated Germ Cell Tumors
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
National Cancer Institute NCI
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2003-10
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 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
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
Detailed Description:
OBJECTIVES
Compare the efficacy of bleomycin etoposide and cisplatin BEP with or without high-dose carboplatin etoposide and cyclophosphamide plus autologous bone marrow or peripheral blood stem cell transplantation in male patients with poor- or intermediate-risk germ cell tumors
Compare the toxicity of these regimens in these patients
Compare prospectively the prognosis in terms of the rate of decline of the serum tumor markers human chorionic gonadotropin hCG and alpha-fetoprotein AFP in patients treated with these regimens
Correlate hCG and AFP with complete response and survival in patients treated with these regimens
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
Arm I Patients receive bleomycin IV on days 1 8 and 15 and etoposide VP-16 IV over 30-60 minutes and cisplatin CDDP IV over 30-60 minutes on days 1-5 BEP Filgrastim G-CSF is administered subcutaneously SC on days 7-16 or until blood counts recover Treatment continues every 3 weeks for 4 courses in the absence of disease progression or unacceptable toxicity G-CSF is discontinued 24 hours before initiating subsequent courses of chemotherapy and withheld on days of bleomycin administration
Arm II Patients receive 2 courses of BEP and G-CSF as in arm I Patients who have no marrow involvement with tumor undergo harvest of autologous bone marrow before the first or second course of BEP Patients who have bone marrow involvement with tumor undergo harvest of G-CSF-mobilized autologous peripheral blood stem cells PBSC on days 17-21 of the first andor second courses of BEP When blood counts recover patients receive high-dose intensification comprising carboplatin IV over 1 hour VP-16 IV over 30-60 minutes and cyclophosphamide IV over 1 hour on days -5 to -3 Autologous bone marrow or PBSC are reinfused over 15-20 minutes on day 0 G-CSF is administered SC beginning 24 hours after transplantation and continuing until blood counts recover Beginning 1-3 weeks after hospital discharge for the first transplantation and after recovery from any toxic effects patients with a Karnofsky performance status of 70-100 receive a second course of high-dose intensification plus a second bone marrow or PBSC transplantation in the absence of disease progression or unacceptable toxicity
Patients on both arms with brain metastases at presentation undergo radiotherapy andor 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 44 years
Compare the efficacy of bleomycin etoposide and cisplatin BEP with or without high-dose carboplatin etoposide and cyclophosphamide plus autologous bone marrow or peripheral blood stem cell transplantation in male patients with poor- or intermediate-risk germ cell tumors
Compare the toxicity of these regimens in these patients
Compare prospectively the prognosis in terms of the rate of decline of the serum tumor markers human chorionic gonadotropin hCG and alpha-fetoprotein AFP in patients treated with these regimens
Correlate hCG and AFP with complete response and survival in patients treated with these regimens
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
Arm I Patients receive bleomycin IV on days 1 8 and 15 and etoposide VP-16 IV over 30-60 minutes and cisplatin CDDP IV over 30-60 minutes on days 1-5 BEP Filgrastim G-CSF is administered subcutaneously SC on days 7-16 or until blood counts recover Treatment continues every 3 weeks for 4 courses in the absence of disease progression or unacceptable toxicity G-CSF is discontinued 24 hours before initiating subsequent courses of chemotherapy and withheld on days of bleomycin administration
Arm II Patients receive 2 courses of BEP and G-CSF as in arm I Patients who have no marrow involvement with tumor undergo harvest of autologous bone marrow before the first or second course of BEP Patients who have bone marrow involvement with tumor undergo harvest of G-CSF-mobilized autologous peripheral blood stem cells PBSC on days 17-21 of the first andor second courses of BEP When blood counts recover patients receive high-dose intensification comprising carboplatin IV over 1 hour VP-16 IV over 30-60 minutes and cyclophosphamide IV over 1 hour on days -5 to -3 Autologous bone marrow or PBSC are reinfused over 15-20 minutes on day 0 G-CSF is administered SC beginning 24 hours after transplantation and continuing until blood counts recover Beginning 1-3 weeks after hospital discharge for the first transplantation and after recovery from any toxic effects patients with a Karnofsky performance status of 70-100 receive a second course of high-dose intensification plus a second bone marrow or PBSC transplantation in the absence of disease progression or unacceptable toxicity
Patients on both arms with brain metastases at presentation undergo radiotherapy andor 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 44 years
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-T94-0086D | Registry Identifier | PDQ Physician Data Query | None |
| MSKCC-94076 | None | None | None |
| CLB-99812 | None | None | None |
| E-3894 | None | None | None |
| CDR0000063820 | REGISTRY | None | None |