Ignite Creation Date:
2025-12-24 @ 5:39 PM
Ignite Modification Date:
2026-02-25 @ 11:05 PM
Study NCT ID:
NCT00039468
Status:
COMPLETED
Last Update Posted:
2011-10-27
First Post:
2002-06-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Thalidomide and Irinotecan in Treating Patients With Glioblastoma Multiforme Who Have Undergone Radiation Therapy
Sponsor:
Dartmouth-Hitchcock Medical Center
Organization:
Study Overview
Official Title:
A Phase II Study Of Thalidomide And CPT-11 (IRINOTECAN) Following Radiotherapy For Glioblastoma Multiforme
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: Thalidomide may stop the growth of glioblastoma multiforme by stopping blood flow to the tumor. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining thalidomide with irinotecan may kill any tumor cells remaining after radiation therapy.
PURPOSE: Phase II trial to study the effectiveness of combining thalidomide with irinotecan in treating patients who have glioblastoma multiforme that has been treated with radiation therapy.
PURPOSE: Phase II trial to study the effectiveness of combining thalidomide with irinotecan in treating patients who have glioblastoma multiforme that has been treated with radiation therapy.
Detailed Description:
OBJECTIVES:
* Determine the response rate of patients with glioblastoma multiforme treated with thalidomide and irinotecan after radiotherapy.
* Determine the preliminary efficacy of this regimen in these patients.
* Determine the disease-free survival and overall survival of patients treated with this regimen.
* Determine the toxicity of this regimen in these patients.
* Assess the quality of life of patients treated with this regimen.
OUTLINE: Beginning 2-4 weeks after completion of radiotherapy, patients receive irinotecan IV over 90 minutes on day 1. Patients also receive oral thalidomide daily. Treatment repeats every 21 days for at least 3 courses in the absence of disease progression or unacceptable toxicity.
Quality of life is assessed at baseline, 1 week after the first course, prior to all subsequent courses, and then after course 6.
Patients are followed for 5 years.
PROJECTED ACCRUAL: A total of 9-24 patients will be accrued for this study.
* Determine the response rate of patients with glioblastoma multiforme treated with thalidomide and irinotecan after radiotherapy.
* Determine the preliminary efficacy of this regimen in these patients.
* Determine the disease-free survival and overall survival of patients treated with this regimen.
* Determine the toxicity of this regimen in these patients.
* Assess the quality of life of patients treated with this regimen.
OUTLINE: Beginning 2-4 weeks after completion of radiotherapy, patients receive irinotecan IV over 90 minutes on day 1. Patients also receive oral thalidomide daily. Treatment repeats every 21 days for at least 3 courses in the absence of disease progression or unacceptable toxicity.
Quality of life is assessed at baseline, 1 week after the first course, prior to all subsequent courses, and then after course 6.
Patients are followed for 5 years.
PROJECTED ACCRUAL: A total of 9-24 patients will be accrued for this study.
Study Oversight
Has Oversight DMC:
True
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?: