SurVaxM Vaccine Therapy and Temozolomide in Treating Patients With Newly Diagnosed Glioblastoma
NCT02455557 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 66
Last updated 2026-03-30
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.
Conditions
- Glioblastoma
- Gliosarcoma
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
-
Given PO or IV
Sponsors & Collaborators
-
Roswell Park Cancer Institute
lead OTHER
Principal Investigators
-
Robert Fenstermaker · Roswell Park Cancer Institute
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2015-05-04
- Primary Completion
- 2019-10-23
- Completion
- 2026-06-02
Countries
- United States
Study Locations
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