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 @ 8:02 PM
Ignite Modification Date:
2025-12-24 @ 8:02 PM
NCT ID:
NCT00004204
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically proven recurrent or progressive malignant glioma of one of the following types:
* Anaplastic oligodendroglioma or oligoastrocytoma
* Anaplastic astrocytoma
* Glioblastoma multiforme (stratum closed to accrual 11/30/01)
* Patients who have failed radiotherapy are eligible
* Measurable disease by CT scan or MRI
PATIENT CHARACTERISTICS:
Age:
* 18 and over
Performance status:
* Karnofsky 70-100%
Life expectancy:
* At least 12 weeks
Hematopoietic:
* Absolute neutrophil count greater than 1,500/mm\^3
* Platelet count greater than 100,000/mm\^3
* Hemoglobin greater than 10 g/dL
Hepatic:
* SGOT or SGPT less than 3 times upper limit of normal (ULN)
* Alkaline phosphatase less than 2 times ULN (if greater than 2 times ULN then a gamma glutamyl transferase test must be performed)
Renal:
* BUN less than 1.5 times ULN
* Creatinine less than 1.5 times ULN
Other:
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective barrier contraception
* No other serious concurrent infection or other medical illness that would preclude study entry
* No frequent vomiting or partial bowel obstruction
* HIV negative
* No AIDS-related illness
* No other concurrent malignancy except carcinoma in situ of the cervix or basal cell skin cancer
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* No concurrent epoetin alfa
Chemotherapy:
* At least 6 weeks since other prior chemotherapy
Endocrine therapy:
* Not specified
Radiotherapy:
* See Disease Characteristics
* At least 3 months since prior radiotherapy (exceptions allowed for recurrent/progressive disease at discretion of primary investigator)
Surgery:
* Recovered from prior surgery
Other:
* No other concurrent investigational agents
* Concurrent anticonvulsant therapy allowed
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00004204
Study Brief:
Protocol Section:
NCT00004204