Vaccination of Patients With Newly Diagnosed Glioblastoma Using Autologous Tumor Lysate and Montanide Emulsion for Derivation of Tumor Specific Hybridomas

Fecha de inicio: 1 de enero de 2014

Inclusion Criteria: Patients with confirmed new diagnosis of glioblastoma and who have a yield of at least 8x10(7) tumor cells obtained at the time of surgery Age > 18 years KPS Score of greater than or equal to 70 Adequate bone marrow as evidenced by: Absolute lymphocyte count > 1,000/uL Platelet count > 50,000/uL Adequate renal function as evidenced by serum creatinine < 2.0 Patients must be able to read, understand and provide informed consent to participate in the trial. Patients of childbearing potential must agree to use an effective form of contraception during the study and for 90 days following vaccination (an effective form of contraception is an oral contraceptive or a double barrier method) Exclusion Criteria: A patient may not be enrolled in the trial if any of the following criteria are met: Patients receiving dexamethasone > 8 mg/day during the week before vaccination. Patients who are pregnant or lactating Patients with active second malignancy. Any other medical conditions, including mental illness or substance abuse, deemed by the Investigator to be likely to interfere with a patient's ability to sign informed consent, cooperate and participate in the study, or interfere with the interpretation of the results.