drugset / Trial / NCT02455557

SurVaxM Vaccine Therapy and Temozolomide in Treating Patients With Newly Diagnosed Glioblastoma

NCT02455557

Phase 2 Active not recruiting 66 enrolled Roswell Park Cancer Institute
NaSingle-groupOpen-labelTreatment

Summary

This phase II trial studies the side effects and how well vaccine therapy works when given together with temozolomide in treating patients with newly diagnosed glioblastoma. Vaccines made from the survivin peptide or antigen may help the body build an effective immune response to kill tumor cells that express survivin. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether temozolomide is more effective with or without vaccine therapy in treating glioblastoma.

Timeline

Start
2015-05-04
Primary completion
2019-10-23
Completion
2026-06-02

Drugs

EvaluationDrugModalityDoseRoute
Subject SVN53-67/M57-KLH Peptide Vaccine Vaccine 500 ug Subcutaneous
Background Temozolomide Small molecule Oral
Background incomplete Freund's adjuvant Other / unclassified Subcutaneous
Background sargramostim Protein / enzyme biologic Subcutaneous

Indications