Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002814
Status:
COMPLETED
Last Update Posted:
2011-10-27
First Post:
1999-11-01
Brief Title:
Combination Chemotherapy for Patients With Brain Cancer
Sponsor:
Dartmouth-Hitchcock Medical Center
Organization:
Dartmouth-Hitchcock Medical Center
Study Overview
Official Title:
A Phase II Trial of Paclitaxel and Topotecan With Filgrastim in Patients With Recurrent or Refractory Glioblastoma Multiforme or Anaplastic Astrocytoma
Status:
COMPLETED
Status Verified Date:
2011-10
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 combination chemotherapy using paclitaxel and topotecan plus G-CSF in treating patients with glioblastoma multiforme or anaplastic astrocytoma that is refractory or recurrent
PURPOSE Phase II trial to study the effectiveness of combination chemotherapy using paclitaxel and topotecan plus G-CSF in treating patients with glioblastoma multiforme or anaplastic astrocytoma that is refractory or recurrent
Detailed Description:
OBJECTIVES I Determine the response rate in patients with refractory or recurrent glioblastoma multiforme or anaplastic astrocytoma treated with paclitaxel TAX and topotecan TOPO with granulocyte colony-stimulating factor G-CSF support II Determine survival in these patients III Describe the toxicity of TAXTOPOG-CSF IV Evaluate tumor p53 expression in relation to response to TAXTOPOG-CSF
OUTLINE All patients receive paclitaxel topotecan and G-CSF every 3 weeks for at least 2 courses and until 2 courses beyond maximum response Patients are followed every 3 months for 2 years then every 6 months for relapse and survival
PROJECTED ACCRUAL A total of 35 patients will be entered if there are 1-3 responses in the first 20 patients
OUTLINE All patients receive paclitaxel topotecan and G-CSF every 3 weeks for at least 2 courses and until 2 courses beyond maximum response Patients are followed every 3 months for 2 years then every 6 months for relapse and survival
PROJECTED ACCRUAL A total of 35 patients will be entered if there are 1-3 responses in the first 20 patients
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 |
|---|---|---|---|
| NCI-V96-0955 | OTHER_GRANT | NCI | None |