Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:39 PM
Ignite Modification Date:
2025-12-24 @ 5:39 PM
NCT ID:
NCT00039468
Eligibility 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00039468
Study Brief:
Protocol Section:
NCT00039468