Ignite Creation Date:
2024-05-05 @ 11:19 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00008008
Status:
COMPLETED
Last Update Posted:
2013-02-04
First Post:
2001-01-06
Brief Title:
Thiotepa Followed by Peripheral Stem Cell or Bone Marrow Transplant in Treating Patients With Malignant Glioma
Sponsor:
Herbert Irving Comprehensive Cancer Center
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
CAMP 013- Tandem Thiotepa Regimen For Selected Malignant Gliomas1 Primary Or Recurrent Glioblastoma Multiforme GBM and 2 Recurrent Anaplastic Astrocytomas AA Oligodendrogliomas O Oligoastrocytomas OA Ependymomas And Primitive Neuroectodermal Tumors PNET That Have Either Progressed After Primary Therapy Or Are Refractory To Standard Chemotherapy
Status:
COMPLETED
Status Verified Date:
2007-07
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 work in different ways to stop tumor cells from dividing so they stop growing or die Giving chemotherapy with peripheral stem cell or bone marrow transplant may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells
PURPOSE This phase II trial is studying how well thiotepa followed by peripheral stem cell or bone marrow transplant works in treating patients with malignant glioma
PURPOSE This phase II trial is studying how well thiotepa followed by peripheral stem cell or bone marrow transplant works in treating patients with malignant glioma
Detailed Description:
OBJECTIVES
Determine the response rate disease-free interval and overall survival of patients with malignant glioma treated with high-dose thiotepa followed by autologous peripheral blood stem cell transplantation
Determine the toxicity of this regimen in these patients
Determine the pharmacokinetics of this regimen in these patients
Determine whether this drug enters the cerebrospinal fluid of these patients
OUTLINE Following a course of induction chemotherapy with cyclophosphamide IV over 4 hours patients receive filgrastim G-CSF daily until the completion of peripheral blood stem cell PBSC harvesting PBSCs are collected over 3-5 days Patients who do not mobilize sufficient cells undergo bone marrow harvest
Patients receive high-dose thiotepa IV over 5 hours on day -2 PBSCs or bone marrow are reinfused on day 0 Patients receive sargramostim GM-CSF subcutaneously daily beginning on day 0 and continuing until blood counts recover Treatment repeats every 2-3 weeks for a total of 1-4 courses in the absence of disease progression or unacceptable toxicity
Quality of life is assessed at baseline at every course then monthly for 6 months and then every 2 months thereafter
Patients are followed monthly for 6 months and then every 2 months thereafter
PROJECTED ACCRUAL A total of 5-40 patients will be accrued for this study within 3 years
Determine the response rate disease-free interval and overall survival of patients with malignant glioma treated with high-dose thiotepa followed by autologous peripheral blood stem cell transplantation
Determine the toxicity of this regimen in these patients
Determine the pharmacokinetics of this regimen in these patients
Determine whether this drug enters the cerebrospinal fluid of these patients
OUTLINE Following a course of induction chemotherapy with cyclophosphamide IV over 4 hours patients receive filgrastim G-CSF daily until the completion of peripheral blood stem cell PBSC harvesting PBSCs are collected over 3-5 days Patients who do not mobilize sufficient cells undergo bone marrow harvest
Patients receive high-dose thiotepa IV over 5 hours on day -2 PBSCs or bone marrow are reinfused on day 0 Patients receive sargramostim GM-CSF subcutaneously daily beginning on day 0 and continuing until blood counts recover Treatment repeats every 2-3 weeks for a total of 1-4 courses in the absence of disease progression or unacceptable toxicity
Quality of life is assessed at baseline at every course then monthly for 6 months and then every 2 months thereafter
Patients are followed monthly for 6 months and then every 2 months thereafter
PROJECTED ACCRUAL A total of 5-40 patients will be accrued for this study within 3 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-G00-1883 | None | None | None |
| CPMC-IRB-8017 | None | None | None |
| CPMC-CAMP-013 | None | None | None |