A Vaccine Trial for Low Grade Gliomas

Inclusion Criteria:

Tumor Type

• Unresectable low-grade gliomas that have received at least two chemotherapy/biologicregimens. Radiation therapy counts as a biologic regimen. Patients may not havereceived radiation therapy to the index lesion within 1 year of enrollment. Patientsmay have tumor spread within the central nervous system (CNS).

• HLA-A2 positive based on flow cytometry.

• Patients must be clinically stable and off or on low-dose (no more than 0.1mg/kg/day, max 4 mg/day Dexamethasone) corticosteroid for at least one week prior tostudy registration.

• Patients must be ≥ 12 months and < 22 years of age at the time of HLA-A2 screening.

• Patients must have a performance status of ≥ 70; (Karnofsky if > 16 years and Lanskyif ≤ 16 years of age.

• Documented negative serum beta-human chorionic gonadotropin (HCG) for femalepatients who are post-menarchal. Because the effect of the peptide-based vaccine andpoly-ICLC on the fetus has not sufficiently been investigated, pregnant females willnot be included in the study.

• Patients must be free of systemic infection requiring IV antibiotics at the time ofregistration. Patients must be off IV antibiotics for at least 7 days prior toregistration.

• Patients with adequate organ function as measured by: Bone marrow: absoluteneutrophil count (ANC) > 1,000/µ; Platelets > 100,000/µ (transfusion independent);absolute lymphocyte count of ≥ 500/µ; Hemoglobin >8 g/dl (may be transfused).Hepatic: bilirubin < 1.5x institutional normal for age; serum glutamate pyruvatetransaminase (SGPT) < 3x institutional normal.

• Renal: Serum creatinine based on age or Creatinine clearance or radioisotopeglomerular filtration rate (GFR) ≥ 70 ml/min/ml/min/1.73 m²

• Patients must have recovered from the toxic effects of prior therapy to grade 1 orbetter. Patients must be at least 3 weeks from the last dose of standard cytotoxicchemotherapy or myelosuppressive biological therapy and at least 1 week from thelast dose of non-myelosuppressive biologic therapy.

• No overt cardiac, gastrointestinal, pulmonary or psychiatric disease.

Exclusion Criteria:

• Patients living outside of North America are not eligible.

• Patients may not have received radiation to the index lesion within 1 year ofenrollment.

• 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 disordersrequiring cytotoxic or immunosuppressive therapy, or autoimmune disorders withvisceral involvement.

• Use of immunosuppressives within four weeks prior to study entry or anticipated useof immunosuppressive agents. Dexamethasone, or other corticosteroid medications, ifused in the peri-operative period must be tapered to no more than 0.1 mg/kg/day, max 4 mg/day dexamethasone for at least one week before study registration. Topicalcorticosteroids are acceptable.

• Because patients with immune deficiency are not expected to respond to this therapy,HIV-positive patients are excluded from the study.

• Patients who have received prior immunotherapy.