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:
2025-12-25 @ 12:31 AM
Ignite Modification Date:
2025-12-25 @ 12:31 AM
NCT ID:
NCT00003067
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically or radiographically proven primary, recurrent, or refractory malignant gliomas (glioblastoma, anaplastic astrocytoma, and mixed anaplastic glioma)
* Must be a candidate for neurosurgical biopsy or tumor debulking
PATIENT CHARACTERISTICS:
Age:
* 18 and over
Performance Status:
* Karnofsky 60-100%
Life Expectancy:
* Greater than 4 months
Hematopoietic:
* Granulocytes greater than 1,500/mm\^3
* Platelet count greater than 50,000/mm\^3
* PT and PTT within normal limits
Hepatic:
* Bilirubin no greater than 1.5 times upper limit of normal
Renal:
* Creatinine less than 1.5 mg/dL
* Creatinine clearance greater than 60 mL/min
Cardiovascular:
* No congestive heart failure
* No coronary artery disease
* No serious cardiac arrhythmias
* No prior myocardial infarction
Pulmonary:
* No major pulmonary problems
Other:
* No history of neurologic disease (except related to brain tumor)
* No psychosis
* No impaired cognitive function
* No significant concurrent medical illness
* No active infection requiring antibiotic therapy
* Not pregnant
* Negative pregnancy test
* Fertile patients must use effective contraception
* Adequate peripheral veins to permit leukapheresis, or placement of indwelling central vascular access device
* No hepatitis B or C
* HIV negative
* No prior autoimmune disease
* Allergy to gentamicin is allowed
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* At least 6 weeks since prior immunotherapy and recovered
* No concurrent immunotherapy
Chemotherapy:
* At least 4 weeks since prior chemotherapy (6 weeks for carmustine) and recovered
* No concurrent chemotherapy
Endocrine therapy:
* Reduction or elimination of corticosteroids
* Not greater than 0.15 mg/kg/day dexamethasone equivalent
Radiotherapy:
* At least 6 weeks since prior radiotherapy and recovered
* No concurrent radiotherapy
Surgery:
* Prior surgery is allowed
Other:
* Concurrent therapy with acetaminophen, anticonvulsant agents, and headache pain medications is allowed
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00003067
Study Brief:
Protocol Section:
NCT00003067