Vaccine for Patients With Newly Diagnosed or Recurrent Low-Grade Glioma

PRIMARY OBJECTIVES:

I. To determine the 5-year progression-free survival (PFS), using intradermal injections of autologous dendritic cells harvested from peripheral blood precursors and pulsed (co-cultured) with tumor lysate derived from surgical tissues in patients with low-grade gliomas.

SECONDARY OBJECTIVES:

I. To monitor overall survival (OS), and cellular immune responses in brain tumor patients injected with tumor lysate-pulsed dendritic cells.

OUTLINE:

Patients receive tumor lysate-pulsed autologous dendritic cell vaccine intradermally (ID) on days 0, 14, and 28.

Inclusion criteria

• Patients with newly diagnosed or recurrent glioma of World Health Organization (WHO) grade II (astrocytoma, oligodendroglioma, and/or oligoastrocytoma) will be eligible for this protocol
• Patients must have had surgical resection at University of California, Los Angeles (UCLA), for which a separate informed consent was signed for the collection of their tumor prior to surgery
• After surgery, a pathological diagnosis of low-grade glioma (WHO grade II) will need to be established
• Patients must be 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.
• 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
• Hemoglobin >= 9 gm%
• Absolute granulocyte count >= 1,500
• Platelet count >= 100,000/microliter (uL)
• Serum glutamic pyruvate transaminase (SGPT), serum glutamic oxaloacetic transaminase (SGOT) =< 2.5 times institutional normals
• Bilirubin =< 1.5mg%
• Blood urea nitrogen (BUN) or creatinine =< 1.5 times institutional normals

Exclusion criteria

• Subjects with an active infection
• Inability to obtain informed consent because of psychiatric or complicating medical problems
• Unstable or severe intercurrent medical or psychiatric conditions as determined by the Investigator
• Females of child-bearing potential who are pregnant or lactating or who are not using approved contraception
• History of immunodeficiency (e.g., human immunodeficiency virus [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
• Subjects with organ allografts
• Inability or unwillingness to return for required visits and follow-up exams
• Subjects who have an uncontrolled systemic malignancy that is not in remission