Vaccine Therapy in Treating Patients With Malignant Glioma

RATIONALE: Vaccines made from a person's white blood cells mixed with tumor proteins may make the body build an immune response to kill tumor cells.

PURPOSE: This phase I trial is studying the side effects and best dose of vaccine therapy in treating patients with malignant glioma.

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.

Eligibility Criteria:
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