Pittsburgh, Pennsylvania 15224


Purpose:

The study will assess the immunogenicity, safety and preliminary clinical efficacy of the GAA/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.


Study summary:

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).


Criteria:

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 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-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: 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; SGPT (ALT) < 3x institutional normal. - Renal: Serum creatinine based on age or Creatinine clearance or radioisotope 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.


NCT ID:

NCT02358187


Primary Contact:

Principal Investigator
Scott Maurer, MD
Children's Hospital of Pittsburgh of UPMC

Scott Maurer, MD
Phone: 412 692-5055


Backup Contact:

Email: carole.rimer@chp.edu
Carole Rimer, RN
Phone: 412 692-7336


Location Contact:

Pittsburgh, Pennsylvania 15224
United States

Carole Rimer, RN
Phone: 412-692-7336
Email: carole.rimer@chp.edu

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: November 23, 2017

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