Cellular Immunotherapy Study for Brain Cancer

Inclusion criteria

To participate in this clinical trial, patients must meet the following eligibility criteria:

• Subjects must have a histologically proven diagnosis of malignant glioma or meningioma and been treated with prior standard radiation and chemotherapy. There must be evidence of unequivocal progression by MRI.
• Tumor must be amenable to resection, and surgical resection must be clinically indicated.
• Age at least 18 years.
• Karnofsky performance scale score >60.
• Adequate hematologic function: a) systemic white blood cell count greater than 2 x 103/mm3, b) platelet count greater than 100,000/mm3, c) hematocrit greater than 25%.
• Adequate renal function, with creatinine less than two times the upper limit.
• Adequate hepatic function, with SGOT, alkaline phosphatase, and total bilirubin < 2x upper limit of normal.
• Patients must have an expected survival of at least three months.
• Patients must not have a history of HTLV, HIV, syphilis by RPR, hepatitis B and C.
• Patients must sign an informed consent.

Exclusion criteria

Patients will be excluded from the trial if the patients:

• have multifocal tumors, bihemispheric tumors, infratentorial tumors, or non-surgically accessible tumors.
• have prior tumor resections where the ventricles were extensively breached.
• are pregnant or breast-feeding women.
• are females of child-bearing potential unable or unwilling to practice adequate birth control methods.
• have contraindications for brain MRI scanning (e.g., intra-ocular metal fragments, cerebral aneurysm clips, pacemaker).
• have concurrent malignancy, excluding curatively treated basal or squamous cell carcinoma of the skin, or carcinoma in situ of the cervix.
• have concurrent systemic infection.
• have any clinically significant, uncontrolled medical illness, as determined by the investigators.
• are unwilling or unable to comply with procedures required in this protocol.