Phase 1 Study of Safety, Tolerability and Immunological Effects of SVN53-67/M57-KLH (012410-2) in Patients with Survivin-Positive Malignant Gliomas

Title Phase 1 Study of Safety, Tolerability and Immunological Effects of SVN53-67/M57-KLH (012410-2) in Patients with Survivin-Positive Malignant Gliomas

Contact KH

Principal Investigator Robert Fenstermaker, MD

Study Number 171010

Phase1

Summary

This is a Phase I study in HLA-A*02 and HLA-A*03 patients with survivin-positive malignant gliomas. It is designed to test the safety and tolerability of a cancer vaccine regimen consisting of the peptide conjugate SVN53-67/M57-KLH in Montanide.

Objectives: To determine the toxicity profile of the SVN53-67/M57-KLH peptide in Montanide ISA 51 plus with GM-CSF in patients with malignant glioma. To measure the immune responses induced by SVN53-67/M57-KLH with Montanide ISA 51 plus GM-CSF. To collect preliminary data on therapeutic efficacy of this combination against malignant glioma.

Eligibility

Please see Cinicaltrails.gov listing for current eligibility criteria

For more information about the clinical study go to Clinicaltrial.Gov