Ignite Creation Date:
2024-05-05 @ 10:17 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002489
Status:
COMPLETED
Last Update Posted:
2013-06-26
First Post:
1999-11-01
Brief Title:
Combination Chemotherapy in Treating Children With Non-testicular Malignant Germ Cell Tumors
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
Memorial Sloan Kettering Cancer Center
Study Overview
Official Title:
PROTOCOL FOR THE TREATMENT OF MALIGNANT NON-TESTICULAR GERM CELL TUMORS
Status:
COMPLETED
Status Verified Date:
2013-06
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 Combining more than one drug may kill more tumor cells
PURPOSE Phase II trial to study the effectiveness of combination chemotherapy in treating children who have non-testicular malignant germ cell tumors
PURPOSE Phase II trial to study the effectiveness of combination chemotherapy in treating children who have non-testicular malignant germ cell tumors
Detailed Description:
OBJECTIVES I Determine the efficacy of cyclophosphamide carboplatin and etoposide in patients with non-testicular malignant germ cell tumors II Improve the quality of life of these patients by shortening the length of treatment and the extent of initial surgical resection III Determine whether histologic subtypes have prognostic significance IV Determine the efficacy of short term chemotherapy in this patient population V Determine the role of second look surgery in predicting curability of non testicular germ cell tumors VI Determine the role of dose intensification of cyclophosphamide and the introduction of doxorubicin methotrexate and dactinomycin for those patients with partial response no response or progressive disease at the time of second look surgery
OUTLINE Patients undergo treatment on Regimen A consisting of surgical resection of tumor as appropriate for disease followed by chemotherapy with cyclophosphamide IV over 20 minutes on day 1 carboplatin IV on day 2 and etoposide IV on days 2-4 Patients receive filgrastim G-CSF subcutaneously SQ daily beginning 24-48 hours following the last dose of etoposide and continuing for 14 days or until blood counts recover a total of 28 days Chemotherapy repeats every 3 weeks for 4 courses in the absence of disease progression At week 11 patients undergo second look surgery to evaluate response and resect any residual disease Patients with no residual disease receive no further therapy Patients with good partial response or no response receive salvage chemotherapy on Regimen B Patients receive salvage chemotherapy on Regimen B consisting of dactinomycin IV on days 1-3 doxorubicin IV and vincristine IV continuously on days 1-3 and G-CSF SQ daily beginning 24-48 hours following last dose of vincristine and continuing for 14 days or until blood counts recover At week 3 patients receive cyclophosphamide IV on days 1-2 vincristine IV and doxorubicin IV continuously on days 1-3 and G-CSF as previously given in Regimen B At week 6 patients receive methotrexate IV on day 1 and leucovorin calcium orally or IV every 6 hours for 3 days beginning 16 hours after the completion of methotrexate At week 8 salvage chemotherapy repeats for an additional course Patients achieving complete response following salvage chemotherapy receive no further therapy Patients with no response are removed from study
PROJECTED ACCRUAL A maximum of 25 patients will be accrued for this study over 6 years
OUTLINE Patients undergo treatment on Regimen A consisting of surgical resection of tumor as appropriate for disease followed by chemotherapy with cyclophosphamide IV over 20 minutes on day 1 carboplatin IV on day 2 and etoposide IV on days 2-4 Patients receive filgrastim G-CSF subcutaneously SQ daily beginning 24-48 hours following the last dose of etoposide and continuing for 14 days or until blood counts recover a total of 28 days Chemotherapy repeats every 3 weeks for 4 courses in the absence of disease progression At week 11 patients undergo second look surgery to evaluate response and resect any residual disease Patients with no residual disease receive no further therapy Patients with good partial response or no response receive salvage chemotherapy on Regimen B Patients receive salvage chemotherapy on Regimen B consisting of dactinomycin IV on days 1-3 doxorubicin IV and vincristine IV continuously on days 1-3 and G-CSF SQ daily beginning 24-48 hours following last dose of vincristine and continuing for 14 days or until blood counts recover At week 3 patients receive cyclophosphamide IV on days 1-2 vincristine IV and doxorubicin IV continuously on days 1-3 and G-CSF as previously given in Regimen B At week 6 patients receive methotrexate IV on day 1 and leucovorin calcium orally or IV every 6 hours for 3 days beginning 16 hours after the completion of methotrexate At week 8 salvage chemotherapy repeats for an additional course Patients achieving complete response following salvage chemotherapy receive no further therapy Patients with no response are removed from study
PROJECTED ACCRUAL A maximum of 25 patients will be accrued for this study over 6 years
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
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-V92-0021 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000077384 | REGISTRY | None | None |