Randomized Phase II Trial of Intralesional Lymphokine Activated Killer Cells or Polifeprosan 20 With Carmustine Implant (Gliadel® Wafer) as Consolidation Therapy After Primary Treatment of Newly Diagnosed Resectable Glioblastoma

Inclusion 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)