A Phase II Study Of Thalidomide And CPT-11 (IRINOTECAN) Following Radiotherapy For Glioblastoma Multiforme
18 Years
N/A
Both
Brain and Central Nervous System Tumors
Trial Information
A Phase II Study Of Thalidomide And CPT-11 (IRINOTECAN) Following Radiotherapy For Glioblastoma Multiforme
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.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Histologically confirmed glioblastoma multiforme (GBM)
- Recurrent disease allowed
- Evaluable disease on contrast-enhanced MRI
- Prior external beam radiotherapy required
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- Karnofsky 60-100%
Life expectancy:
- Not specified
Hematopoietic:
- Absolute neutrophil count at least 1,500/mm^3
- Platelet count at least 100,000/mm^3
Hepatic:
- Bilirubin no greater than 1.5 times upper limit of normal (ULN)
- AST or ALT no greater than 5 times ULN
Renal:
- Creatinine no greater than 1.5 times ULN OR
- Creatinine clearance at least 60 mL/min
Cardiovascular:
- No significant cardiac disease
- No uncontrolled high blood pressure
- No unstable angina
- No congestive heart failure
- No myocardial infarction within the past 3 months
- No serious cardiac arrhythmias
Gastrointestinal:
- Able to take oral medication
- No gastrointestinal abnormalities
- No requirement for IV alimentation
- No active peptic ulcer disease
Other:
- No active infection
- No serious uncontrolled medical disorder
- No dementia or significantly altered mental status that would preclude study
- No known hypersensitivity to irinotecan or thalidomide
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use 2 forms of effective contraception, including 1 highly
effective method, at least 1 month before, during, and for 1 month after study
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- No prior thalidomide
Chemotherapy:
- No prior irinotecan
- At least 4 weeks since other prior chemotherapy (and demonstrated evidence of disease
progression or relapse)
Endocrine therapy:
- Concurrent corticosteroids allowed if on a stable or decreasing dose for at least 1
week prior to study
- No concurrent hormonal therapy for GBM
Radiotherapy:
- See Disease Characteristics
- No concurrent radiotherapy for GBM
Surgery:
- No prior surgical procedures affecting absorption
Other:
- No other concurrent anticancer investigational agents for GBM
- No concurrent cytochrome P450 inhibitors, including the following:
- Nefazodone
- Fluvoxamine
- Fluoxetine
- Sertraline
- Paroxetine
- Venlafaxine
- Ketoconazole
- Itraconazole
- Fluconazole
- Cimetadine
- Clarithromycin
- Diltiazem
- Erythromycin
- Protease inhibitors
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Response
Outcome Description:
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.
Outcome Time Frame:
2 years
Safety Issue:
No
Principal Investigator
Camilo E. Fadul, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Norris Cotton Cancer Center
Authority:
United States: Federal Government
Study ID:
D0134
NCT ID:
NCT00039468
Start Date:
March 2002
Completion Date:
February 2008
Related Keywords:
- Brain and Central Nervous System Tumors
- adult glioblastoma
- recurrent adult brain tumor
- adult giant cell glioblastoma
- adult gliosarcoma
- Glioblastoma
- Nervous System Neoplasms
- Central Nervous System Neoplasms
Name | Location |
|---|---|
| Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center | Lebanon, New Hampshire 03756-0002 |
| Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University | Columbus, Ohio 43210-1240 |
