Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003141
Status:
COMPLETED
Last Update Posted:
2014-03-28
First Post:
1999-11-01
Brief Title:
Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Infants With Malignant Brain or Spinal Cord Tumors
Sponsor:
Childrens Oncology Group
Organization:
Childrens Oncology Group
Study Overview
Official Title:
A Pilot Study of Intensive Chemotherapy With Peripheral Stem Cell Support for Infants With Malignant Brain Tumors
Status:
COMPLETED
Status Verified Date:
2014-03
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 chemotherapy with peripheral stem cell transplantation may allow the doctors to give higher doses of chemotherapy drugs and kill more tumor cells
PURPOSE Phase I trial to study the effectiveness of combination chemotherapy plus peripheral stem cell transplantation in treating infants with malignant brain or spinal cord tumors
PURPOSE Phase I trial to study the effectiveness of combination chemotherapy plus peripheral stem cell transplantation in treating infants with malignant brain or spinal cord tumors
Detailed Description:
OBJECTIVES
Determine the maximum tolerated dose of thiotepa in infants with malignant brain or spinal cord tumors receiving intensive chemotherapy
Determine the feasibility and toxicity of intensive chemotherapy with peripheral blood stem cell PBSC rescue in these patients
Assess the feasibility of harvesting PBSCs in these patients
Determine the complete response rate and overall event-free survival rate in patients treated with this regimen
OUTLINE This is a pilot multicenter study
Patients undergo surgery for diagnosis and maximal tumor resection
Within 6 weeks of surgery or when stable patients begin induction chemotherapy comprising cisplatin IV over 6 hours on day 0 vincristine IV on days 0 7 and 14 cyclophosphamide IV over 1 hour on days 1-2 and etoposide IV over 1 hour on days 0-2 Twenty four hours after the last cyclophosphamide dose patients receive filgrastim G-CSF subcutaneously SC and undergo peripheral blood stem cell harvest 2 days later Treatment repeats every 21 days for up to 3 courses in the absence of disease progression or unacceptable toxicity
Within 6 weeks after induction chemotherapy patients receive consolidation chemotherapy comprising carboplatin IV over 2 hours on days 0-1 followed immediately by escalating doses of thiotepa IV over 2 hours Patients then undergo peripheral blood stem cell transplantation 48 hours after the last thiotepa dose Patients receive G-CSF SC daily on days 3 to 21 Treatment repeats every 21 days for up to 3 courses in the absence of disease progression or unacceptable toxicity
Patients experiencing dose-limiting toxicity due to thiotepa are removed from the study
Patients are followed at 4 weeks every 3 months for 1 year every 6 months for 3 years and then annually for 3 years or until relapse
PROJECTED ACCRUAL A total of 83 patients will be accrued for this study within 1 year
Determine the maximum tolerated dose of thiotepa in infants with malignant brain or spinal cord tumors receiving intensive chemotherapy
Determine the feasibility and toxicity of intensive chemotherapy with peripheral blood stem cell PBSC rescue in these patients
Assess the feasibility of harvesting PBSCs in these patients
Determine the complete response rate and overall event-free survival rate in patients treated with this regimen
OUTLINE This is a pilot multicenter study
Patients undergo surgery for diagnosis and maximal tumor resection
Within 6 weeks of surgery or when stable patients begin induction chemotherapy comprising cisplatin IV over 6 hours on day 0 vincristine IV on days 0 7 and 14 cyclophosphamide IV over 1 hour on days 1-2 and etoposide IV over 1 hour on days 0-2 Twenty four hours after the last cyclophosphamide dose patients receive filgrastim G-CSF subcutaneously SC and undergo peripheral blood stem cell harvest 2 days later Treatment repeats every 21 days for up to 3 courses in the absence of disease progression or unacceptable toxicity
Within 6 weeks after induction chemotherapy patients receive consolidation chemotherapy comprising carboplatin IV over 2 hours on days 0-1 followed immediately by escalating doses of thiotepa IV over 2 hours Patients then undergo peripheral blood stem cell transplantation 48 hours after the last thiotepa dose Patients receive G-CSF SC daily on days 3 to 21 Treatment repeats every 21 days for up to 3 courses in the absence of disease progression or unacceptable toxicity
Patients experiencing dose-limiting toxicity due to thiotepa are removed from the study
Patients are followed at 4 weeks every 3 months for 1 year every 6 months for 3 years and then annually for 3 years or until relapse
PROJECTED ACCRUAL A total of 83 patients will be accrued for this study within 1 year
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 |
|---|---|---|---|
| CDR0000065924 | OTHER | Clinical Trialsgov | None |
| COG-99703 | OTHER | None | None |
| CCG-99703 | OTHER | None | None |