A Phase II Study of Vaccinations With HLA-A2 Restricted Glioma Antigen Peptides in Combination With Poly-ICLC for Children With Recurrent Unresectable Low-Grade Gliomas (LGG)

Trial ID: NCT02358187

Interventional - Phase 2 - Recruiting

The study will assess the immunogenicity, safety and preliminary clinical efficacy of the glioma associated antigen (GAA)/tetanus toxoid (TT) peptide vaccine and poly-ICLC in HLA-A2+ children with unresectable low-grade gliomas that have received at least two chemotherapy/biologic regimens. Radiation therapy counts as one biologic regimen, but patients may not have received radiation to the index lesion within 1 year of enrollment.

Conditions

• Low Grade Glioma

Interventions

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

Eligibility

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.

Sponsor

James Felker, Connor's Cure, National Cancer Institute (NCI)

Source: ClinicalTrials.gov

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