A Pilot Study of Glioma Associated Antigen Vaccines in Conjunction with Poly-ICLC in Pediatric Gliomas

Exclusion Criteria

• •HLA-A2 positive based on flow cytometry.
• •Patients in Stratum A B and E must have received standard involved field radiation therapy \[RT\] defined as fractionated external beam radiotherapy with total doses between 5000-6000 cGy. Patients in these strata must be registered within 4-12 weeks of completing RT.
• •Patients in Stratum F must have received craniospinal radiation.
• •Patients must be clinically stable and off or on low-dose (no more than 0.1 mg/kg/day, max 4 mg/day Dexamethasone) corticosteroid for at least one week prior to study registration.
• •All patients must sign an IRB-approved informed consent document
• •Patients must be ≥ 12 months and \<22 years of age at the time of study registration.
• •Patients must have a performance status of ≥ to 60.
• •Patients must have life expectancy of at least 8 weeks.
• •Documented negative serum βHCG for female patients who are post-menarchal. Pregnant females will not be included in the study. Males and females must agree to use effective birth control methods during the course of vaccination.
• •Patients must be free of systemic infection.
• •Patients with adequate organ function as measured by: Bone marrow: ANC \> 1,000/µl; Platelets \> 100,000/µl (transfusion independent); absolute lymphocyte count of ≥500/uL; Hemoglobin \>8 g/dl (may be transfused). Hepatic: bilirubin ≤ 1.5x institutional normal for age; SGPT (ALT) \< 3x institutional normal.
• •Renal: Serum creatinine based on age or Creatinine clearance or radioisotope GFR \>70 ml/min/ml/min/1.73 m²
• •Patients on Strata C and D must have recovered from the toxic effects of prior therapy: at least 3 weeks form the last dose of standard cytotoxic chemotherapy or myelosuppressive biological therapy and at least 1 week from the last dose of non-myelosuppressive biologic therapy.
• •No overt cardiac, gastrointestinal, pulmonary or psychiatric disease.
• •Presence of metastatic disease for patients in Stratum A, B, D and E. Patients with low grade gliomas (stratum C) may have tumor spread within the CNS.
• •Patients in Stratum F must have tumor spread within the CNS.
• •Patients enrolled in Strata A and B may not have received any prior chemotherapy or anti-glioma therapy of any type other than radiation therapy. Patients enrolled on stratum C must have received at least two prior chemotherapy or biologic therapy regimens and may not have received radiation to the index lesion within 1 year of enrollment. Patients on Strata A, B, E, and F can not have received chemotherapy after radiation therapy was completed.
• •Concurrent treatment or medications (must be off for at least 1 week) including:
• •Interferon (e.g. Intron-A®)
• •Allergy desensitization injections
• •Growth factors (e.g. Procrit®, Aranesp®, Neulasta®)
• •Interleukins (e.g. Proleukin®)
• •Any investigational therapeutic medication
• •Patients must not have a history of, or currently active autoimmune disorders.
• •Use of immunosuppressives within four weeks prior to study entry. Dexamethasone, or other corticosteroid medications, if used in the peri-operative period and/or during radiotherapy, must be tapered (no more than 0.1 mg/kg/day, max 4 mg/day dexamethasone) for at least one week before study registration. Topical corticosteroids are acceptable.
• •Patients with known addiction to alcohol or illicit drugs.