Ignite Creation Date:
2024-05-05 @ 11:30 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00053118
Status:
COMPLETED
Last Update Posted:
2011-03-01
First Post:
2003-01-27
Brief Title:
Chemotherapy and Stem Cell Transplantation in Treating Children With Central Nervous System Cancer
Sponsor:
Roswell Park Cancer Institute
Organization:
Roswell Park Cancer Institute
Study Overview
Official Title:
High Dose Carboplatin Combined With Oral VP-16 In The Treatment Of Pediatric CNS Malignancies
Status:
COMPLETED
Status Verified Date:
2011-02
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 Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells
PURPOSE Phase I trial to study the effectiveness of combining chemotherapy with peripheral stem cell transplantation in treating children who have central nervous system cancer
PURPOSE Phase I trial to study the effectiveness of combining chemotherapy with peripheral stem cell transplantation in treating children who have central nervous system cancer
Detailed Description:
OBJECTIVES
Determine the feasibility of administering an outpatient protocol comprising high-dose carboplatin with autologous stem cell support and etoposide in pediatric patients with primary central nervous system malignancies
Determine the maximum tolerated dose of carboplatin when administered in this regimen in these patients
Determine the toxicity of this regimen in these patients
OUTLINE This is dose-escalation study of carboplatin
Patients receive filgrastim G-CSF IV once daily for 6 days followed by a maximum of 5 apheresis sessions If the target number of peripheral blood stem cells is not achieved some patients receive G-CSF and undergo apheresis as above after a 2-week rest
At least 3 days after completion of G-CSF patients receive high-dose carboplatin IV over 1 hour on day 1 stem cell reinfusion on day 3 G-CSF subcutaneously on days 4-18 and 43-61 and oral etoposide 3 times daily on days 21-42 Treatment continues for a maximum of 4 courses in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of carboplatin until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity
Patients are followed monthly for 1 year and then annually thereafter
PROJECTED ACCRUAL A total of 3-15 patients will be accrued for this study
Determine the feasibility of administering an outpatient protocol comprising high-dose carboplatin with autologous stem cell support and etoposide in pediatric patients with primary central nervous system malignancies
Determine the maximum tolerated dose of carboplatin when administered in this regimen in these patients
Determine the toxicity of this regimen in these patients
OUTLINE This is dose-escalation study of carboplatin
Patients receive filgrastim G-CSF IV once daily for 6 days followed by a maximum of 5 apheresis sessions If the target number of peripheral blood stem cells is not achieved some patients receive G-CSF and undergo apheresis as above after a 2-week rest
At least 3 days after completion of G-CSF patients receive high-dose carboplatin IV over 1 hour on day 1 stem cell reinfusion on day 3 G-CSF subcutaneously on days 4-18 and 43-61 and oral etoposide 3 times daily on days 21-42 Treatment continues for a maximum of 4 courses in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of carboplatin until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity
Patients are followed monthly for 1 year and then annually thereafter
PROJECTED ACCRUAL A total of 3-15 patients will be accrued for this study
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 |
|---|---|---|---|
| RPCI-DS-00-03 | None | None | None |