Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00025324
Status:
UNKNOWN
Last Update Posted:
2013-12-18
First Post:
2001-10-11
Brief Title:
Chemotherapy Surgery Radiation Therapy and Bone Marrow or Peripheral Stem Cell Transplantation in Treating Patients With Primary CNS Germ Cell Tumors
Sponsor:
Childrens Hospital Los Angeles
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Clinical Correlative Studies In Primary Central Nervous System Germ Cell Tumors The Third International CNS Germ Cell Tumor Study Group Protocol
Status:
UNKNOWN
Status Verified Date:
2004-12
Last Known Status:
ACTIVE_NOT_RECRUITING
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 Peripheral stem cell transplantation or bone marrow transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells Radiation therapy uses high-energy x-rays to damage tumor cells
PURPOSE Phase II trial to study the effectiveness of chemotherapy surgery radiation therapy and bone marrow or peripheral stem cell transplantation in treating patients who have primary CNS germ cell tumors
PURPOSE Phase II trial to study the effectiveness of chemotherapy surgery radiation therapy and bone marrow or peripheral stem cell transplantation in treating patients who have primary CNS germ cell tumors
Detailed Description:
OBJECTIVES
Determine the two-year event-free survival of patients with primary CNS germ cell tumors treated with carboplatin etoposide cyclophosphamide and filgrastim G-CSF with or without radiotherapy andor high-dose chemotherapy with autologous bone marrow or peripheral blood stem cell transplantation
Determine the prognostic significance of slow-responding tumor marker normalization in patients treated with this regimen
Determine the prognostic significance of syncytiotrophoblastic giant cell component and cerebrospinal fluid beta-human chorionic gonadotropin elevation in patients treated with this regimen
Assess the early and late endocrinologic neuropsychometric and quality of life sequelae in patients treated with this regimen
OUTLINE This is a multicenter study Patients are stratified according to risk status low vs intermediate or high
Regimen A Low-risk patients
Chemotherapy Patients receive carboplatin IV over 4 hours and etoposide IV over 2 hours on days 1-2 and filgrastim G-CSF subcutaneously SC once daily beginning on day 3 and continuing until blood counts recover course 1 Patients also receive cyclophosphamide IV over 1 hour and etoposide IV over 2 hours on days 22 and 23 and G-CSF SC once daily beginning on day 24 and continuing until blood counts recover course 2
Patients with complete response CR to initial chemotherapy receive 2 additional courses of chemotherapy as above and then proceed to observational phase Patients with partial response PR to initial chemotherapy receive 2 additional courses of chemotherapy as above
Patients with CR after additional chemotherapy receive another 2 additional courses of chemotherapy as above and then proceed to observational phase Patients with PR after additional chemotherapy undergo biopsy andor resection of residual tumor
Patients with evidence of malignant germ cell tumor GCT on resection undergo radiotherapy Patients with no evidence of malignant GCT on resection but with scar fibrosis or mature teratoma receive 2 additional courses of chemotherapy as above and then proceed to observational phase Patients with no evidence of malignant GCT on resection but with immature teratoma receive carboplatin IV over 4 hours cyclophosphamide IV over 1 hour and etoposide IV over 2 hours on days 1-2 and 22-23 Patients who underwent complete resection of residual tumor proceed to observational phase Patients who underwent a biopsy only or an incomplete resection of residual tumor undergo radiotherapy
Regimen B Intermediate and high-risk patients
Patients receive carboplatin IV over 4 hours cyclophosphamide IV over 1 hour and etoposide IV over 2 hours on days 0-1 Patients also receive G-CSF SC once daily beginning on day 2 and continuing until blood counts recover Treatment repeats every 21 days for a total of 2 courses Patients undergo bone marrow or peripheral blood stem cell harvest prior to second course of chemotherapy
Patients with rapid CR to 2 initial courses of chemotherapy receive an additional 2 courses of chemotherapy as above and then proceed to observational phase Patients with a PR or slow response to 2 initial courses of chemotherapy receive 2 additional courses of chemotherapy as above Patients with a CR to courses 3 and 4 receive 2 more courses of chemotherapy and then proceed to observational phase Patients with a PR to courses 3 and 4 undergo a biopsy andor resection of residual tumor
Patients with no evidence of malignant GCT on resection but with scar fibrosis or mature teratoma receive carboplatin IV over 4 hours and etoposide IV over 2 hours on days 1 and 2 and cyclophosphamide IV over 1 hour and etoposide IV over 2 hours on days 22 and 23 and proceed to observational phase Patients with teratoma on resection receive additional treatment as in regimen A Patients with evidence of pure germinoma on resection undergo radiotherapy
Patients with evidence of other malignant GCT on resection undergo high-dose chemotherapy HDCx with bone marrow or peripheral blood stem cell support PBSCS comprising thiotepa IV over 3 hours and etoposide IV over 1 hour on days -8 through -6 carboplatin IV over 4 hours on days -5 through -3 reinfusion of autologous bone marrow or peripheral blood stem cells on day 0 and G-CSF SC or IV every 12 hours beginning on day 1 and continuing until blood counts recover Patients then undergo radiotherapy
Quality of life is assessed before bone marrow or PBSCS and then every 2 years thereafter
Patients are followed at day 42 at 3 months then every 3 months for 1 year every 4 months for 1 year every 6 months for 3 years and then annually thereafter
PROJECTED ACCRUAL A total of 80 patients 40 per stratum will be accrued for this study within 4 years
Determine the two-year event-free survival of patients with primary CNS germ cell tumors treated with carboplatin etoposide cyclophosphamide and filgrastim G-CSF with or without radiotherapy andor high-dose chemotherapy with autologous bone marrow or peripheral blood stem cell transplantation
Determine the prognostic significance of slow-responding tumor marker normalization in patients treated with this regimen
Determine the prognostic significance of syncytiotrophoblastic giant cell component and cerebrospinal fluid beta-human chorionic gonadotropin elevation in patients treated with this regimen
Assess the early and late endocrinologic neuropsychometric and quality of life sequelae in patients treated with this regimen
OUTLINE This is a multicenter study Patients are stratified according to risk status low vs intermediate or high
Regimen A Low-risk patients
Chemotherapy Patients receive carboplatin IV over 4 hours and etoposide IV over 2 hours on days 1-2 and filgrastim G-CSF subcutaneously SC once daily beginning on day 3 and continuing until blood counts recover course 1 Patients also receive cyclophosphamide IV over 1 hour and etoposide IV over 2 hours on days 22 and 23 and G-CSF SC once daily beginning on day 24 and continuing until blood counts recover course 2
Patients with complete response CR to initial chemotherapy receive 2 additional courses of chemotherapy as above and then proceed to observational phase Patients with partial response PR to initial chemotherapy receive 2 additional courses of chemotherapy as above
Patients with CR after additional chemotherapy receive another 2 additional courses of chemotherapy as above and then proceed to observational phase Patients with PR after additional chemotherapy undergo biopsy andor resection of residual tumor
Patients with evidence of malignant germ cell tumor GCT on resection undergo radiotherapy Patients with no evidence of malignant GCT on resection but with scar fibrosis or mature teratoma receive 2 additional courses of chemotherapy as above and then proceed to observational phase Patients with no evidence of malignant GCT on resection but with immature teratoma receive carboplatin IV over 4 hours cyclophosphamide IV over 1 hour and etoposide IV over 2 hours on days 1-2 and 22-23 Patients who underwent complete resection of residual tumor proceed to observational phase Patients who underwent a biopsy only or an incomplete resection of residual tumor undergo radiotherapy
Regimen B Intermediate and high-risk patients
Patients receive carboplatin IV over 4 hours cyclophosphamide IV over 1 hour and etoposide IV over 2 hours on days 0-1 Patients also receive G-CSF SC once daily beginning on day 2 and continuing until blood counts recover Treatment repeats every 21 days for a total of 2 courses Patients undergo bone marrow or peripheral blood stem cell harvest prior to second course of chemotherapy
Patients with rapid CR to 2 initial courses of chemotherapy receive an additional 2 courses of chemotherapy as above and then proceed to observational phase Patients with a PR or slow response to 2 initial courses of chemotherapy receive 2 additional courses of chemotherapy as above Patients with a CR to courses 3 and 4 receive 2 more courses of chemotherapy and then proceed to observational phase Patients with a PR to courses 3 and 4 undergo a biopsy andor resection of residual tumor
Patients with no evidence of malignant GCT on resection but with scar fibrosis or mature teratoma receive carboplatin IV over 4 hours and etoposide IV over 2 hours on days 1 and 2 and cyclophosphamide IV over 1 hour and etoposide IV over 2 hours on days 22 and 23 and proceed to observational phase Patients with teratoma on resection receive additional treatment as in regimen A Patients with evidence of pure germinoma on resection undergo radiotherapy
Patients with evidence of other malignant GCT on resection undergo high-dose chemotherapy HDCx with bone marrow or peripheral blood stem cell support PBSCS comprising thiotepa IV over 3 hours and etoposide IV over 1 hour on days -8 through -6 carboplatin IV over 4 hours on days -5 through -3 reinfusion of autologous bone marrow or peripheral blood stem cells on day 0 and G-CSF SC or IV every 12 hours beginning on day 1 and continuing until blood counts recover Patients then undergo radiotherapy
Quality of life is assessed before bone marrow or PBSCS and then every 2 years thereafter
Patients are followed at day 42 at 3 months then every 3 months for 1 year every 4 months for 1 year every 6 months for 3 years and then annually thereafter
PROJECTED ACCRUAL A total of 80 patients 40 per stratum will be accrued for this study within 4 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-G01-2019 | None | None | None |
| CHLA-NYU-0007H | None | None | None |