Clinical Trial Finder

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)

OBJECTIVES:

• - To compare the side effects, including infections and/or abnormal healing at the surgery site, associated with intralesional lymphokine-activated killer (LAK) cells vs.#46;polifeprosan 20 with carmustine implant (Gliadel® wafer) as consolidation therapy for patients with newly diagnosed resectable glioblastoma multiforme.

• - To compare the overall survival of patients treated with these regimens.

OUTLINE: Patients are stratified according to age (< 50 vs.#46;≥ 50 years of age), Karnofsky performance status (70-80% vs.#46;90-100%), use of corticosteroids > 4 mg/day (yes vs.#46;no), and progressive disease during first-line therapy (yes vs.#46;no). Patients are randomized to 1 of 2 treatment arms.

• - Arm I: Patients undergo intracranial placement of polifeprosan 20 with carmustine implant (Gliadel® wafer) at the time of therapeutic craniotomy.

• - Arm II: Patients undergo leukapheresis to obtain autologous lymphokine-activated killer (LAK) cells, followed 3-7 days later by therapeutic craniotomy.

The autologous LAK cells are then instilled into the tumor bed cavity at the time of therapeutic craniotomy. After completion of study treatment, patients are followed periodically for up to 5 years.

Arms

Experimental: Arm I

Patients undergo intracranial placement of polifeprosan 20 with carmustine implant (Gliadel® wafer) at the time of therapeutic craniotomy.

Experimental: Arm II

Patients undergo leukapheresis to obtain autologous lymphokine-activated killer (LAK) cells, followed 3-7 days later by therapeutic craniotomy. The autologous LAK cells are then instilled into the tumor bed cavity at the time of therapeutic craniotomy.

Interventions

Biological: - lymphokine-activated killer cells

Instilled into the tumor bed cavity

Drug: - polifeprosan 20 with carmustine implant

Intracranial placement