RECRUITING

A Vaccine Trial for Low Grade Gliomas

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Conditions

Low Grade Glioma

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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)

Quick Facts

Study Start:2015-01
Study Completion:2025-08-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT02358187

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:12 Months to 21 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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).
  2. * HLA-A2 positive based on flow cytometry.
  3. * 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.
  4. * Patients must be ≥ 12 months and \< 22 years of age at the time of HLA-A2 screening.
  5. * Patients must have a performance status of ≥ 70; (Karnofsky if \> 16 years and Lansky if ≤ 16 years of age.
  6. * 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.
  7. * 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.
  8. * 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.
  9. * Renal: Serum creatinine based on age or Creatinine clearance or radioisotope glomerular filtration rate (GFR) ≥ 70 ml/min/ml/min/1.73 m²
  10. * 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.
  11. * No overt cardiac, gastrointestinal, pulmonary or psychiatric disease.
  1. * Patients living outside of North America are not eligible.
  2. * Patients may not have received radiation to the index lesion within 1 year of enrollment.
  3. * Concurrent treatment or medications (must be off for at least 1 week) including:
  4. * Interferon (e.g. Intron-A®)
  5. * Allergy desensitization injections
  6. * Growth factors (e.g. Procrit®, Aranesp®, Neulasta®)
  7. * Interleukins (e.g. Proleukin®)
  8. * Any investigational therapeutic medication
  9. * Patients must not have a history of, or currently active autoimmune disorders requiring cytotoxic or immunosuppressive therapy, or autoimmune disorders with visceral involvement.
  10. * 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.
  11. * Because patients with immune deficiency are not expected to respond to this therapy, HIV-positive patients are excluded from the study.
  12. * Patients who have received prior immunotherapy.

Contacts and Locations

Study Contact

James Felker, MD
CONTACT
412 692-5055
Sharon Dibridge
CONTACT
412-692-7070
sharon.dibridge@chp.edu

Principal Investigator

James Felker, MD
PRINCIPAL_INVESTIGATOR
University of Pittsburgh

Study Locations (Sites)

Children's Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania, 15224
United States

Collaborators and Investigators

Sponsor: James Felker

  • James Felker, MD, PRINCIPAL_INVESTIGATOR, University of Pittsburgh

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2015-01
Study Completion Date2025-08-31

Study Record Updates

Study Start Date2015-01
Study Completion Date2025-08-31

Terms related to this study

Additional Relevant MeSH Terms

  • Low Grade Glioma