Clinical Trial Finder

Eligibility Criteria:

• - Histologically confirmed diagnosis of one of the following malignant gliomas: - Anaplastic astrocytoma.

• - Glioblastoma multiforme.

• - Anaplastic oligodendroglioma.

• - Malignant mixed oligoastrocytoma.

• - WHO grade III or IV disease.

• - Newly diagnosed disease.

• - Bidimensionally measurable disease by contrast-enhancing MRI.

• - Surgically accessible tumor for which resection is indicated.

• - Previously treated with or plan to undergo treatment with conventional external beam radiotherapy.

• - Age 18 and over.

• - Performance status Karnofsky 60-100% - Life expectancy at least 8 weeks.

• - Hemoglobin at least 10 g/dL.

• - Absolute granulocyte count at least 1,500/mm^3.

• - Platelet count at least 100,000/mm^3.

• - SGOT and SGPT no greater than 2 times normal.

• - Alkaline phosphatase no greater than 2 times normal.

• - Bilirubin no greater than 1.5 mg/dL.

• - Hepatitis B negative.

• - Hepatitis C negative.

• - BUN no greater than 1.5 times normal.

• - Creatinine no greater than 1.5 times normal.

• - HIV negative.

• - Syphilis serology negative.

• - Afebrile.

• - Negative pregnancy test.

• - Fertile patients must use effective contraception.

• - At least 2 weeks since prior chemotherapy (6 weeks for nitrosoureas) and recovered.

• - At least 2 weeks since prior corticosteroids.

• - At least 2 weeks since prior radiotherapy and recovered.

• - More than 72 hours since prior systemic antibiotics.

Exclusion Criteria:

• - active infection.

• - immunodeficiency.

• - autoimmune disease that may be exacerbated by immunotherapy, including any of the following: - Rheumatoid arthritis.

• - Systemic lupus erythematosus.

• - Vasculitis.

• - Polymyositis-dermatomyositis.

• - Scleroderma.

• - Multiple sclerosis.

• - Juvenile-onset insulin-dependent diabetes.

• - allergy to study agents.

• - pregnant or nursing.

• - underlying condition that would contraindicate study therapy.

• - concurrent severe or unstable medical condition that would preclude giving informed consent.

• - psychiatric condition that would preclude study participation or giving informed consent.

• - other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, localized prostate cancer, or carcinoma in situ of the cervix.

• - concurrent chemotherapy during and for 2 weeks after administration of study vaccine.

• - concurrent corticosteroids prior organ allograft.

• - antihistamine therapy within 5 days before or after administration of study vaccine.

• - other concurrent investigational agents.

- concurrent adjuvant therapy during and for 2 weeks after administration of study vaccine

OBJECTIVES:

• - Determine the dose-limiting toxicity and maximum tolerated dose of autologous tumor lysate-pulsed dendritic cells in patients with malignant gliomas.

• - Determine survival, tumor progression, and cellular immune response in patients treated with this regimen.

OUTLINE: This is a dose-escalation study. Patients undergo leukapheresis for the collection of peripheral blood mononuclear cells (PBMC). Autologous dendritic cells (DC) are prepared from autologous PBMC exposed to sargramostim (GM-CSF) and interleukin-4 and pulsed with autologous tumor lysate. Patients receive autologous tumor lysate-pulsed DC intradermally on days 0, 14, and 28 in the absence of unacceptable toxicity. Cohorts of 6-12 patients receive escalating doses of autologous tumor lysate-pulsed DC until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Patients are followed every 2 months for 2 years. PROJECTED ACCRUAL: A total of 3-18 patients will be accrued for this study within 9-18 months.

Arms

Experimental: autologous tumor lysate-pulsed DC

Interventions

Biological: - therapeutic autologous dendritic cells