Immunotherapy for Recurrent Ependymomas in Children Using Tumor Antigen Peptides With Imiquimod

Inclusion Criteria: All grades of ependymoma are eligible.

• Patients must have recurrent/progressive ependymoma that has progressed or recurredafter initial adjuvant therapy.

• HLA-A2 positive based on flow cytometry performed at the University of Pittsburgh.

• Patients must have previously received standard initial therapy including attemptedgross total resection, where safely feasible, and in appropriate circumstances (e.g., those older than one year at initial diagnosis, with non-metastatic tumorsand at least microscopic residual disease), involved field fractionated radiationtherapy (RT). Patients may have received re-irradiation but not to the index lesionwithin 4 weeks.

• 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 study registration.

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

• Patients may have non-bulky, asymptomatic metastatic disease.

• Males and females must agree to use effective birth control methods during thecourse of vaccination (from the first vaccine to two weeks after the last vaccine).

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

• Patients must have adequate organ function as measured by:

• Bone marrow: Absolute neutrophil count (ANC) > 1,000/µl; Platelets > 100,000/µl (transfusion independent); Absolute lymphocyte count (ALC) ≥ 500/µl; Hemoglobin >8 g/dl (may be transfused).

• Hepatic: bilirubin ≤ 1.5x institutional normal for age; serum glutamatepyruvate transaminase (SGPT) < 3x institutional normal

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

• Patients must have recovered from the toxic effects of prior therapy and be at least 3 weeks from the last dose of standard cytotoxic chemotherapy or myelosuppressivebiological therapy, at least one week from the last dose of non-myelosuppressivebiological therapy and at least 4 weeks from the completion of radiation therapy.

• Patients must have no overt cardiac, gastrointestinal, pulmonary, or psychiatricdisease.

Patients must be willing to travel to Pittsburgh to receive the vaccine. Visits: Every 3 weeks x 9, then every 6 weeks x 12 depending on response/side effects

Exclusion Criteria:

• Patients living outside of North America are not eligible.

• Patients must be off concurrent treatment or medications for at least 1 weekincluding: Interferon (e.g. Intron-A®), allergy desensitization injections, growthfactors (e.g. Procrit®, Aranesp®, Neulasta®), interleukins (e.g. Proleukin®), andany investigational therapeutic medication.

• Patients must not have a history of any immune system disorder or laboratoryabnormality or any condition that could potentially alter immune function.

• Use of immunosuppressives within four weeks prior to study entry or anticipated useof immunosuppressive agents. Patients must be on no more than 0.1 mg/kg/day, max 4mg/day dexamethasone for at least one week before study registration. Topicalcorticosteroids are acceptable.

• Patients with a known immune deficiency.

• Pregnancy or breastfeeding. Female patients who are post-menarchal must have adocumented negative pregnancy test.

• Tetanus vaccine during therapy or within 1 week prior to enrollment.

• Patients who have received prior immunotherapy.