A Phase II Clinical Trial Evaluating Autologous Dendritic Cells Pulsed With Tumor Lysate Antigen +/- Toll-like Receptor Agonists for the Treatment of Malignant Glioma

Inclusion Criteria

PATIENT ELIGIBILITY

Inclusion Criteria

1. Patients with newly diagnosed or recurrent glioma of WHO Grade III or IV {anaplastic
astrocytoma (AA), anaplastic astro-oligodendroglioma (AO), or glioblastoma (GBM)}
will be eligible for this protocol.

2. Patients must have had surgical resection at UCLA (University of California, Los
Angeles), for which a separate informed consent was signed for the collection of
their tumor prior to surgery.

3. After surgery, a pathological diagnosis of malignant glioma (WHO Grade III or IV)
will need to be established.

4. Patients must be 18 years or older and able to read and understand the informed
consent document. Patients must sign the informed consent indicating that they are
aware of the investigational nature of this study.

5. Patients must have a Karnofsky performance status (KPS) rating of > 60 prior to
initiating treatment. Patients may be enrolled at a KPS of < 60 if it is felt that
the patient will have adequate opportunity to recover to a KPS of > 60 by the
initiation of treatment.

Exclusion Criteria

1. Subjects with an active infection.

2. Inability to obtain informed consent because of psychiatric or complicating medical
problems.

3. Unstable or severe intercurrent medical or psychiatric conditions as determined by
the Investigator.

4. Females of child-bearing potential who are pregnant or lactating or who are not using
approved contraception.

5. History of immunodeficiency (e.g., HIV) or autoimmune disease (e.g., rheumatoid
arthritis, systemic lupus erythematosus, vasculitis, polymyositis-dermatomyositis,
scleroderma, multiple sclerosis, or juvenile-onset insulin-dependent diabetes) that
may be exacerbated by immunotherapy.

6. Subjects with organ allografts.

7. Inability or unwillingness to return for required visits and follow-up exams.

8. Subjects who have an uncontrolled systemic malignancy that is not in remission.