Ignite Creation Date:
2024-05-05 @ 10:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00007982
Status:
COMPLETED
Last Update Posted:
2013-02-04
First Post:
2001-01-06
Brief Title:
Chemotherapy Plus Peripheral Stem Cell Transplant in Treating Patients With Central Nervous System Cancer
Sponsor:
Herbert Irving Comprehensive Cancer Center
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
CAMP 004A - Phase 2 Study Of Intensive Chemotherapy BET For Selected Categories Of Malignant Central Nervous System Tumor
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 use different ways to stop cancer cells from dividing so they stop growing or die Combining chemotherapy with peripheral stem cell transplant may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells
PURPOSE This phase II trial is studying how well chemotherapy and peripheral stem cell transplant work in treating patients with central nervous system cancer
PURPOSE This phase II trial is studying how well chemotherapy and peripheral stem cell transplant work in treating patients with central nervous system cancer
Detailed Description:
OBJECTIVES
Determine the response rate in patients with central nervous system malignancies treated with intensive chemotherapy supported by autologous peripheral blood stem cell transplantation following surgical resection andor radiotherapy
Determine the disease-free survival and overall survival of this patient population treated with these regimens
Determine the toxicity of this high-dose chemotherapy regimen in these patients
Assess the quality of life of these patients following these treatment regimens
OUTLINE Patients with anaplastic astrocytoma esthesioneuroblastoma germ cell tumor or primary neuroectodermal tumor undergo initial surgical resection followed by conventional or stereotactic radiotherapy Patients with germ cell or primary neuroectodermal tumors also receive 4 courses of standard chemotherapy comprising cyclophosphamide etoposide and cisplatin prior to high-dose chemotherapy
All patients undergo peripheral blood stem cell or bone marrow harvest followed by high-dose chemotherapy consolidation Patients receive thiotepa IV 3 times daily on days -7 to -3 carmustine IV over 1 hour on days -6 to -3 and etoposide IV over 5 hours on days -6 to -3 Patients then undergo transplantation on day 0 Filgrastim G-CSF is administered concurrently with stem cell harvesting and transplantation
Patients with recurrent oligodendroglioma or CNS lymphoma who have not received radiotherapy at diagnosis undergo conventional radiotherapy 6 weeks after completion of high-dose chemotherapy
Patients are followed every 2-3 months for 1 year and then annually for 5 years Quality of life is assessed at follow-up
PROJECTED ACCRUAL A total of 30 patients will be accrued for this study over 3 years
Determine the response rate in patients with central nervous system malignancies treated with intensive chemotherapy supported by autologous peripheral blood stem cell transplantation following surgical resection andor radiotherapy
Determine the disease-free survival and overall survival of this patient population treated with these regimens
Determine the toxicity of this high-dose chemotherapy regimen in these patients
Assess the quality of life of these patients following these treatment regimens
OUTLINE Patients with anaplastic astrocytoma esthesioneuroblastoma germ cell tumor or primary neuroectodermal tumor undergo initial surgical resection followed by conventional or stereotactic radiotherapy Patients with germ cell or primary neuroectodermal tumors also receive 4 courses of standard chemotherapy comprising cyclophosphamide etoposide and cisplatin prior to high-dose chemotherapy
All patients undergo peripheral blood stem cell or bone marrow harvest followed by high-dose chemotherapy consolidation Patients receive thiotepa IV 3 times daily on days -7 to -3 carmustine IV over 1 hour on days -6 to -3 and etoposide IV over 5 hours on days -6 to -3 Patients then undergo transplantation on day 0 Filgrastim G-CSF is administered concurrently with stem cell harvesting and transplantation
Patients with recurrent oligodendroglioma or CNS lymphoma who have not received radiotherapy at diagnosis undergo conventional radiotherapy 6 weeks after completion of high-dose chemotherapy
Patients are followed every 2-3 months for 1 year and then annually for 5 years Quality of life is assessed at follow-up
PROJECTED ACCRUAL A total of 30 patients will be accrued for this study over 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 |
|---|---|---|---|
| CPMC-IRB-8445 | None | None | None |
| CPMC-CAMP-004A | None | None | None |
| NCI-G00-1881 | None | None | None |