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NCT02455557 · ClinicalTrials.gov registry record · Phase 2
SurVaxM Vaccine Therapy and Temozolomide in Treating Patients With Newly Diagnosed Glioblastoma
A Phase 2 study of Glioblastoma and Gliosarcoma, sponsored by Roswell Park Cancer Institute.
- Active
- Registry status
- Phase 2
- Development phase
- 66
- Enrollment target
- 5
- Study locations
NCT02455557: Active Phase 2 study of Glioblastoma and Gliosarcoma, sponsored by Roswell Park Cancer Institute.
NCT02455557 is a Phase 2 study of Glioblastoma and Gliosarcoma that is active but no longer recruiting, run by Roswell Park Cancer Institute. The registered enrollment target is 66 participants, below the 109-participant average among 199 other Glioblastoma trials with a reported enrollment target (39% lower). The trial reports 5 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02455557, a Phase 2 study of Glioblastoma and Gliosarcoma, is active but no longer recruiting, sponsored by Roswell Park Cancer Institute.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 66 participants
- Enrollment target
- 5
- Study locations
Study 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.
Primary Outcome
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.
Conditions Studied
Interventions
- OTHER Laboratory Biomarker Analysis
- DRUG Temozolomide
- BIOLOGICAL Sargramostim
- BIOLOGICAL SVN53-67/M57-KLH Peptide Vaccine
- DRUG Montanide ISA 51 VG
Study Locations (5)
Massachusetts
- Massachusetts General Hospital Cancer Center - Boston
- Dana-Farber Harvard Cancer Center - Boston
- Beth Israel Deaconess Medical Center - Boston
New York
- Roswell Park Cancer Institute - Buffalo
Ohio
- Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center - Cleveland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 66 participants |
| Start Date | 2015-05-04 |
| Est. Completion | 2026-03-02 |
| Phase | Phase 2 |
What the registry record for NCT02455557 still lists
NCT02455557 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 66 participants, a relatively small participant target, below the 109-participant average among 199 other Glioblastoma trials with a reported enrollment target (39% lower).
The record links to 2 conditions, with Glioblastoma appearing as the primary indexed condition, and to 5 interventions - of which Laboratory Biomarker Analysis is the first listed.
NCT02455557 lists 5 locations in 3 states (Massachusetts, New York, Ohio).
Frequently Asked Questions
What is clinical trial NCT02455557 about?
NCT02455557 is a clinical study titled "SurVaxM Vaccine Therapy and Temozolomide in Treating Patients With Newly Diagnosed Glioblastoma". 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 th...
What is the current status of trial NCT02455557?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 66 participants. The study started on 2015-05-04. Estimated completion is 2026-03-02.
What conditions does trial NCT02455557 study?
This clinical trial studies the following conditions: Glioblastoma, Gliosarcoma.
What interventions are being tested in trial NCT02455557?
The interventions under investigation include: Laboratory Biomarker Analysis (OTHER), Temozolomide (DRUG), Sargramostim (BIOLOGICAL), SVN53-67/M57-KLH Peptide Vaccine (BIOLOGICAL), Montanide ISA 51 VG (DRUG).
Who is sponsoring clinical trial NCT02455557?
This trial is sponsored by Roswell Park Cancer Institute, which has 365 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02455557 being conducted?
This trial has 5 study locations across Massachusetts, New York, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT02455557's enrollment target sits among peer trials
66 67th of 199 higher than 132 of 199 other Glioblastoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Glioblastoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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