Vaccine for Patients With Newly Diagnosed or Recurrent Low-Grade Glioma
Condition: Adult Diffuse Astrocytoma; Adult Mixed Glioma; Adult Oligodendroglioma; Recurrent Adult Brain Tumor; Adult Oligoastrocytoma
MeSH terms: Glioma; Astrocytoma; Oligodendroglioma
Intervention: tumor lysate-pulsed autologous dendritic cell vaccine; laboratory biomarker analysis
Intervention description: Given ID; Correlative studies
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 5.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The primary purpose of this phase II clinical trial is to determine the safety and effect on
      survival of patients autologous dendritic cells pulsed with autologous tumor lysate as a
      treatment for low-grade glioma patients. Other goals of this study are to determine if the
      vaccine can cause an immune response against patients' cancer cells and slow the growth of
      their brain tumors
    

Eligibility criteria:

        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