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 @ 11:44 PM
Ignite Modification Date:
2025-12-24 @ 11:44 PM
NCT ID:
NCT00005951
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed recurrent primary malignant glioma
* Anaplastic astrocytoma
* Glioblastoma multiforme
* Anaplastic oligodendroglioma
* Gliosarcoma
* Anaplastic mixed oligoastrocytoma
* Measurable disease by MRI or CT
* No immediate radiotherapy required
* Neurologically stable for at least 2 weeks prior to study
PATIENT CHARACTERISTICS:
Age:
* 18 and over
Performance status:
* Karnofsky 60-100%
Life expectancy:
* Greater than 12 weeks
Hematopoietic:
* Absolute neutrophil count at least 1,500/mm\^3
* Platelet count at least 100,000/mm\^3
* Hemoglobin at least 10 g/dL
Hepatic:
* Bilirubin less than 1.5 times upper limit of normal (ULN)
* SGOT and SGPT less than 2.5 times ULN
* Alkaline phosphatase less than 2 times ULN
Renal:
* Blood urea nitrogen and creatinine less than 1.5 times ULN
Other:
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* HIV negative
* No other nonmalignant systemic disease
* No acute infection treated with IV antibiotics
* No frequent vomiting or other condition that would preclude oral medication administration (e.g., partial bowel obstruction)
* No other prior malignancies except surgically cured carcinoma in situ of the cervix or basal or squamous cell skin cancer
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* No more than 1 prior biologic therapy regimen
Chemotherapy:
* No more than 1 prior chemotherapy regimen
* At least 6 weeks since prior chemotherapy, unless evidence of disease progression
* No prior failure of irinotecan or temozolomide
Endocrine therapy:
* Concurrent corticosteroids allowed
Radiotherapy:
* See Disease Characteristics
* At least 6 weeks since prior radiotherapy, unless evidence of disease progression
Surgery:
* At least 3 weeks since prior surgery, unless evidence of disease progression, and recovered
Other:
* No concurrent immunosuppressive agents
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00005951
Study Brief:
Protocol Section:
NCT00005951