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ACTIVE NOT RECRUITING
NCT02455557
PHASE2

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

Sponsor: Roswell Park Cancer Institute

View on ClinicalTrials.gov

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.

Official title: A Phase II Study of the Safety and Efficacy of SVN53-67/M57-KLH (SurVaxM) in Survivin-Positive Newly Diagnosed Glioblastoma

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

66

Start Date

2015-05-04

Completion Date

2026-06-02

Last Updated

2026-03-30

Healthy Volunteers

No

Interventions

OTHER

Laboratory Biomarker Analysis

Correlative studies

DRUG

Montanide ISA 51 VG

Given SC

BIOLOGICAL

Sargramostim

Given SC

BIOLOGICAL

SVN53-67/M57-KLH Peptide Vaccine

Given SC

DRUG

Temozolomide

Given PO or IV

Locations (5)

Massachusetts General Hospital Cancer Center

Boston, Massachusetts, United States

Dana-Farber Harvard Cancer Center

Boston, Massachusetts, United States

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Roswell Park Cancer Institute

Buffalo, New York, United States

Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

Cleveland, Ohio, United States