Thalidomide and Irinotecan in Treating Patients With Glioblastoma Multiforme Who Have Undergone Radiation Therapy
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|ClinicalTrials.gov Identifier: NCT00039468|
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : October 27, 2011
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.
|Condition or disease||Intervention/treatment||Phase|
|Brain and Central Nervous System Tumors||Drug: irinotecan hydrochloride Drug: thalidomide||Phase 2|
- 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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||26 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study Of Thalidomide And CPT-11 (IRINOTECAN) Following Radiotherapy For Glioblastoma Multiforme|
|Study Start Date :||March 2002|
|Actual Primary Completion Date :||September 2007|
|Actual Study Completion Date :||February 2008|
- Drug: irinotecan hydrochloride
350 or 700 mg/m2 IV every 3 weeksOther Name: CAMPTOSAR
- Drug: thalidomide
400mg/day oralOther Name: THALOMID
- Response [ Time Frame: 2 years ]To evaluate the response rate and hence preliminary efficacy of Irinotecan and Thalidomide following radiotherapy in the treatment of newly diagnosed or relapsed glioblastoma multiforme.
- Toxicity / QOL / Survival [ Time Frame: 2 years ]To evaluate 1) toxicity 2) quality of life 3) disease free survival and 4) overall survival of patients treated with this combination.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00039468
|United States, New Hampshire|
|Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center|
|Lebanon, New Hampshire, United States, 03756-0002|
|United States, Ohio|
|Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University|
|Columbus, Ohio, United States, 43210-1240|
|Study Chair:||Camilo E. Fadul, MD||Norris Cotton Cancer Center|