Clinical Trial Finder

Inclusion Criteria:

Tumor Type.

• - Unresectable low-grade gliomas that have received at least two chemotherapy/biologic regimens.

Radiation therapy counts as a biologic regimen. Patients may not have received radiation therapy to the index lesion within 1 year of enrollment. Patients may 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 0.1 mg/kg/day, max 4 mg/day Dexamethasone) corticosteroid for at least one week prior to study 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 Lansky if ≤ 16 years of age.

• - Documented negative serum beta-human chorionic gonadotropin (HCG) for female patients who are post-menarchal.

Because the effect of the peptide-based vaccine and poly-ICLC on the fetus has not sufficiently been investigated, pregnant females will not be included in the study.

• - Patients must be free of systemic infection requiring IV antibiotics at the time of registration.

Patients must be off IV antibiotics for at least 7 days prior to registration.

• - Patients with adequate organ function as measured by: Bone marrow: absolute neutrophil 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 pyruvate transaminase (SGPT) < 3x institutional normal.

• - Renal: Serum creatinine based on age or Creatinine clearance or radioisotope glomerular 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 or better.

Patients must be at least 3 weeks from 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.

Exclusion Criteria:

• - Patients living outside of North America are not eligible.

• - Patients may not have received radiation to the index lesion within 1 year of enrollment.

• - 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 requiring cytotoxic or immunosuppressive therapy, or autoimmune disorders with visceral involvement.

• - Use of immunosuppressives within four weeks prior to study entry or anticipated use of immunosuppressive agents.

Dexamethasone, or other corticosteroid medications, if used 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. Topical corticosteroids 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.

Patients will be treated with subcutaneous injections of GAA/TT-vaccines starting on Week 0 and every 3 weeks thereafter for up to 8 cycles or until Off-treatment criteria are met (Section 4.6). I.m. poly-ICLC will be administered (30ug/kg i.m.) immediately following the vaccine. Poly-ICLC should be administered i.m. within 3 cm of the peptide-injection site. To allow for flexibility with scheduling, the peptide vaccine and Poly-ICLC dose may be given within one week of the date that the vaccine and poly-ICLC administration are due. Patients will be evaluated for any possible adverse event, regimen limiting toxicity (RLT) as well as clinical/radiological responses by clinical visits and MRI scanning. Follow-up MRIs will be performed (Weeks 6, 15 and 24).

Arms

Experimental: HLA-A2 Restricted Glioma Antigen-Peptides with Poly-ICLC

All subjects will receive vaccine plus Poly-ICLC. Injections will be given every 3 week for a total of 8 vaccines.

Interventions

Biological: - Experimental: HLA-A2 Restricted Glioma Antigen-Peptides with Poly-ICLC

Poly-ICLC is administered intramuscularly (i.m.) using sterile technique, as supplied from the vial, and in the amount prescribed for the participant's weight. Patients should receive a dose of acetaminophen (15 mg/kg up to a max of 1000 mg) 30-60 minutes before each poly-ICLC administration. The poly-ICLC treatments will be administered immediately following the vaccine. Patients/parents will be asked to report any temperature elevations and side effects after each treatment.