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 @ 1:19 AM
Ignite Modification Date:
2025-12-25 @ 1:19 AM
NCT ID:
NCT00814593
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed primary malignant glioblastoma multiforme (GBM) (i.e., grade IV anaplastic astrocytoma)
* Must have undergone standard primary therapy (e.g., surgery, radiotherapy, and temozolomide) within the past 90 days
* Additional anticancer therapy as part of first-line therapy, including a radiosurgical procedure (e.g., stereotactic or gamma knife radiosurgery) allowed
* Must be an operable candidate and willing to undergo craniotomy
PATIENT CHARACTERISTICS:
* Karnofsky performance status 70-100%
* Life expectancy ≥ 2 months
* Hemoglobin \> 10.0 g/dL
* AGC \> 1,500/mm³
* Platelet count \> 100,000/mm³
* Serum total bilirubin \< 1.5 times upper limit of normal (ULN)
* ALT and AST \< 2.5 times ULN
* Serum creatinine \< 1.5 times ULN
* Negative pregnancy test
* Resides in the United States of America
* Venous access available for leukapheresis procedure to obtain peripheral blood mononuclear cells
* No diagnosis of any other invasive cancer within the past 5 years, except in situ carcinoma or basal cell carcinoma or localized squamous cell carcinoma of the skin
* Patients with prior diagnosis of minimal microscopic cancer (e.g., colonic polyp or stage I prostate cancer with Gleason score \< 6) may be eligible, as determined by the principal investigator
* No concurrent serious medical or psychiatric illness that may interfere with giving informed consent or conducting this study
* No known hypersensitivity or allergy to either carmustine or aldesleukin
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
* At least 3 weeks since prior anticancer therapy and recovered
* No polifeprosan 20 with carmustine implant (Gliadel® wafer) at the time of prior surgery for GBM
* No prior treatment for progressive disease
* No other concurrent anticancer therapy (e.g., continuation of hormonal therapy for breast or prostate cancer that was diagnosed \> 5 years ago)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00814593
Study Brief:
Protocol Section:
NCT00814593