Brief 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.

Trial Health

Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date

Enrollment

participants targeted

Target at P50-P75 for phase_2

Timeline

Completed

Started May 2015

Longer than P75 for phase_2

Geographic Reach

1 country

5 active sites

Status

active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

11.1 years study duration

Study Start

First participant enrolled

May 4, 2015

Completed

18 days until next milestone

First Submitted

Initial submission to the registry

May 22, 2015

Completed

6 days until next milestone

First Posted

Study publicly available on registry

May 28, 2015

Completed

4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 23, 2019

Completed

1.3 years until next milestone

Results Posted

Study results publicly available

February 1, 2021

Completed

5.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 2, 2026

Completed

Last Updated

March 30, 2026

Status Verified

March 1, 2026

Enrollment Period

4.5 years

First QC Date

May 22, 2015

Results QC Date

December 17, 2020

Last Update Submit

March 16, 2026

Conditions

Glioblastoma Gliosarcoma

Outcome Measures

Primary Outcomes (1)

Progression-free Survival (PFS)
The 6-month progression-free survival (PFS6) estimated using the Kaplan-Meier methods. PFS6 is defined as the percentage of patients without tumor progression or death from any cause 6 months after the date of diagnosis by biopsy. Corresponding confidence intervals will be computed.
Date of diagnosis to the date of first observed disease progression or death due to any cause, assessed at 6 months

Secondary Outcomes (3)

Immune Responses to SurVaxM and Predictors of Response
Up to 30 days after completion of study treatment
Incidence of Grade 3 or 4 Toxicities, According to National Cancer Institute Common Toxicity Criteria for Adverse Events Version 4
Up to 30 days after completion of study treatment
Overall Survival
Date of diagnosis until (1) date of death or (2) the last date patient known alive (if death is not observed), assessed up to 2 years

Study Arms (1)

Treatment (SurVaxM, temozolomide)

EXPERIMENTAL

Patients receive the first priming dose of SVN53-67/M57-KLH peptide vaccine in emulsion with montanide ISA 51 SC and sargramostim SC within 7-28 days after completion of chemoradiation. Treatment repeats every 2 weeks for a total of 4 doses in the vaccine priming phase and then every 12 weeks during the adjuvant phase in the absence of disease progression or unacceptable toxicity. Patients also receive standard adjuvant temozolomide PO or IV on days 1-5. Treatment repeats every 28 days for 6 courses or more (at the discretion of the investigator) in the absence of disease progression or unacceptable toxicity. Patients may then receive maintenance SVN53-67/M57-KLH peptide vaccine in emulsion with montanide ISA 51 SC and sargramostim SC every 12 weeks in the absence of disease progression or unacceptable toxicity.

Other: Laboratory Biomarker AnalysisDrug: Montanide ISA 51 VGBiological: SargramostimBiological: SVN53-67/M57-KLH Peptide VaccineDrug: Temozolomide