Ignite Creation Date:
2024-05-05 @ 11:08 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002472
Status:
COMPLETED
Last Update Posted:
2011-03-15
First Post:
1999-11-01
Brief Title:
Cisplatin and Etoposide Prior to Radiation Therapy in Treating Patients With CNS Tumors
Sponsor:
Mayo Clinic
Organization:
Mayo Clinic
Study Overview
Official Title:
Phase II Pre-Irradiation Chemotherapy for Central Nervous System Germ Cell Malignancies
Status:
COMPLETED
Status Verified Date:
2011-03
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 cisplatin and etoposide in treating patients with CNS tumors
PURPOSE Phase II trial to study the effectiveness of cisplatin and etoposide in treating patients with CNS tumors
Detailed Description:
OBJECTIVES
Determine the response rate of patients with newly diagnosed CNS germ cell tumors treated with cisplatin and etoposide
Determine the survival of patients with CNS germ cell tumors treated with cisplatin and etoposide followed by cranial radiotherapy
Determine endocrine and cognitive function in these patients before and after receiving this regimen
OUTLINE Patients are stratified by histology germinoma vs nongerminoma
Patients receive cisplatin IV over 4 hours followed by etoposide IV over 30-60 minutes on days 1-5 Treatment continues every 3 weeks for 4 courses in the absence of disease progression or unacceptable toxicity After completion of 4 courses patients with nongerminoma who achieve complete response CR and all patients with germinoma proceed to radiotherapy After completion of 4 courses patients with nongerminoma who achieve less than CR undergo resection of any residual cranial masses if feasible and then proceed to radiotherapy Patients who experience disease progression or unacceptable toxicity during chemotherapy are restaged and proceed directly to radiotherapy
Beginning a minimum of 3 weeks after completion of the last course of chemotherapy and after recovering from any toxic effects of chemotherapy eligible patients undergo a regimen of craniospinal axis irradiation andor localized cranial or spinal field irradiation based on histology extent of disease and response to chemotherapy Patients with gross spinal meningeal disease after completion of chemotherapy undergo radiotherapy boost
Patients are followed every 2 months for 1 year every 4 months for 1 year every 6 months for 1 year and then annually for 2 years
PROJECTED ACCRUAL A total of 12-25 patients with germinoma will be accrued for this study within 3-6 years A total of 12-25 patients with nongerminoma will be accrued for this study within 6-12 years
Determine the response rate of patients with newly diagnosed CNS germ cell tumors treated with cisplatin and etoposide
Determine the survival of patients with CNS germ cell tumors treated with cisplatin and etoposide followed by cranial radiotherapy
Determine endocrine and cognitive function in these patients before and after receiving this regimen
OUTLINE Patients are stratified by histology germinoma vs nongerminoma
Patients receive cisplatin IV over 4 hours followed by etoposide IV over 30-60 minutes on days 1-5 Treatment continues every 3 weeks for 4 courses in the absence of disease progression or unacceptable toxicity After completion of 4 courses patients with nongerminoma who achieve complete response CR and all patients with germinoma proceed to radiotherapy After completion of 4 courses patients with nongerminoma who achieve less than CR undergo resection of any residual cranial masses if feasible and then proceed to radiotherapy Patients who experience disease progression or unacceptable toxicity during chemotherapy are restaged and proceed directly to radiotherapy
Beginning a minimum of 3 weeks after completion of the last course of chemotherapy and after recovering from any toxic effects of chemotherapy eligible patients undergo a regimen of craniospinal axis irradiation andor localized cranial or spinal field irradiation based on histology extent of disease and response to chemotherapy Patients with gross spinal meningeal disease after completion of chemotherapy undergo radiotherapy boost
Patients are followed every 2 months for 1 year every 4 months for 1 year every 6 months for 1 year and then annually for 2 years
PROJECTED ACCRUAL A total of 12-25 patients with germinoma will be accrued for this study within 3-6 years A total of 12-25 patients with nongerminoma will be accrued for this study within 6-12 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 |
|---|---|---|---|
| T92-0208D | OTHER | NCI protocol | httpsreporternihgovquickSearchP30CA015083 |
| P30CA015083 | NIH | None | None |
| 891351 | OTHER | None | None |