A Vaccine Trial for Low Grade Gliomas

NCT02358187 | Recruiting Phase 2 DMC FDA Drug

• 3 other identifiers: STUDY19060121R01CA187219PRO13110086
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

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

Outcome Measures

Primary Outcomes (1)

• Tumor shrinkage or stable disease

  Participants who demonstrate radiological evidence of tumor shrinkage or stable disease without regimen-limiting toxicity (RLT) after the initial 8 vaccines will be eligible to receive additional vaccinations beginning week 24 and every 6 weeks thereafter for up to two years.

  Week 24

Study Arms (1)

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

EXPERIMENTAL

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

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

Interventions

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

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.

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

Eligibility Criteria

• Age: 12 Months - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Cancer Institute (NCI): collaborator
• James Felker: lead
• Connor's Cure: collaborator

Study Sites (1)

Children's Hospital of Pittsburgh of UPMC

Pittsburgh, Pennsylvania, 15224, United States

RECRUITING

MeSH Terms

Interventions

poly ICLC

Study Officials

• James Felker, MD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Central Study Contacts

James Felker, MD

CONTACT

412 692-5055

Sharon Dibridge

CONTACT

412-692-7070; sharon.dibridge@chp.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: February 3, 2015
• First Posted: February 6, 2015
• Study Start: January 1, 2015
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): December 31, 2028
• Last Updated: January 7, 2026

Record last verified: 2026-01

Locations

US (1)