This phase II trial studies how well vaccine therapy and polyinosinic-polycytidylic acid stabilized with polylysine and carboxymethylcellulose (poly-ICLC) work in treating younger patients with low-grade gliomas that have come back after treatment and cannot be removed by surgery. Vaccines made from peptides may help the body build an effective immune response to kill cancer cells. Giving booster vaccinations may make a stronger immune response and prevent or delay the recurrence of cancer. Giving HLA-A2-restricted synthetic glioma antigen peptides vaccine and tetanus toxoid vaccine with poly-ICLC may work better in treating younger patients with recurrent low-grade gliomas that cannot be removed by surgery.
Additional locations may be listed on ClinicalTrials.gov for NCT02358187.
Locations matching your search criteria
United States
Pennsylvania
Pittsburgh
Children's Hospital of Pittsburgh of UPMCStatus: Active
Contact: Gary E. Mason
Phone: 412-692-5056
PRIMARY OBJECTIVES:
I. Determine the efficacy of vaccination with tumor-associated antigen (TAA) peptides for children with recurrent low-grade gliomas, using objective measures of imaging-based tumor response and progression-free survival.
II. Characterize the rate and magnitude of immune response in post-vaccine peripheral blood mononuclear cells against vaccine peptides, in response to peptide-based vaccine therapy, using interferon (IFN)gamma-enzyme-linked immunosorbent spot (ELISPOT) and tetramer assays, and to correlate immunological response with clinical responses to the vaccine.
III. To further define the safety of the vaccine regimen in children with recurrent low-grade gliomas.
IV. Examine associations between antigen expression in the tumor and treatment response, and mechanisms of immune escape in tumors that progress after immunotherapy, issues that have not yet been systematically examined in these tumors.
OUTLINE:
Beginning week 0, patients receive HLA-A2-restricted synthetic glioma antigen peptides vaccine subcutaneously (SC), tetanus toxoid vaccine SC, and poly-ICLC intramuscularly (IM). Treatment repeats every 3 weeks for up to 8 courses in the absence of disease progression or unacceptable toxicity.
CONTINUATION THERAPY: Patients with evidence of tumor shrinkage or stable disease after initial 8 vaccines may receive additional HLA-A2-restricted synthetic glioma antigen peptides vaccine SC and tetanus toxoid vaccine SC every 6 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 3 months for 1 year, every 6 months for 2 years, and annually for 2 years.
Lead OrganizationChildren's Hospital of Pittsburgh of UPMC
Principal InvestigatorGary E. Mason