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

Launched by JAMES FELKER · Feb 18, 2013

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment for children with recurrent ependymomas, which are a type of brain tumor. The researchers want to find out if a vaccine made from specific tumor proteins, combined with a medication called imiquimod, is safe and can help the body’s immune system fight the cancer. The trial is open to children aged 12 months to 22 years who have had their ependymoma return after previous treatments. To qualify, participants must have certain test results showing they are HLA-A2 positive and must be in good overall health, meaning they haven't had serious infections or other major health issues recently.

If a child joins the study, they will receive the vaccine every three weeks for a total of nine doses, then possibly continue with additional visits every six weeks depending on how they respond to the treatment. It’s important for families to know that participants will need to travel to Pittsburgh for these vaccinations. Additionally, both boys and girls must agree to use effective birth control during the treatment period. This trial is specifically looking for children who have not had certain past treatments or conditions that could affect their immune system.

Gender

ALL

Eligibility criteria

• • Inclusion Criteria: All grades of ependymoma are eligible.
• • Patients must have recurrent/progressive ependymoma that has progressed or recurred after 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 attempted gross total resection, where safely feasible, and in appropriate circumstances (e.g., those older than one year at initial diagnosis, with non-metastatic tumors and at least microscopic residual disease), involved field fractionated radiation therapy (RT). Patients may have received re-irradiation but not to the index lesion within 4 weeks.
• • 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 study registration.
• • Patients must have a performance status of ≥ 70; (Karnofsky if \> 16 years and Lansky if ≤ 16 years of age).
• • Patients may have non-bulky, asymptomatic metastatic disease.
• • Males and females must agree to use effective birth control methods during the course 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 of registration 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 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/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 myelosuppressive biological therapy, at least one week from the last dose of non-myelosuppressive biological therapy and at least 4 weeks from the completion of radiation therapy.
• • Patients must have no overt cardiac, gastrointestinal, pulmonary, or psychiatric disease.
• • 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 week including: Interferon (e.g. Intron-A®), allergy desensitization injections, growth factors (e.g. Procrit®, Aranesp®, Neulasta®), interleukins (e.g. Proleukin®), and any investigational therapeutic medication.
• • Patients must not have a history of any immune system disorder or laboratory abnormality or any condition that could potentially alter immune function.
• • Use of immunosuppressives within four weeks prior to study entry or anticipated use of immunosuppressive agents. Patients must be on 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 a known immune deficiency.
• • Pregnancy or breastfeeding. Female patients who are post-menarchal must have a documented negative pregnancy test.
• • Tetanus vaccine during therapy or within 1 week prior to enrollment.
• • Patients who have received prior immunotherapy.