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NCT01250470 · ClinicalTrials.gov registry record · Phase 1
Vaccine Therapy and Sargramostim in Treating Patients With Malignant Glioma
A Phase 1 study, sponsored by Roswell Park Cancer Institute.
- Completed
- Registry status
- Phase 1
- Development phase
- 9
- Enrollment target
NCT01250470: Completed Phase 1 study, sponsored by Roswell Park Cancer Institute.
NCT01250470 is a Phase 1 study that has completed, run by Roswell Park Cancer Institute. The registered enrollment target is 9 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (85% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01250470, a Phase 1 study, has completed, sponsored by Roswell Park Cancer Institute.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 9 participants
- Enrollment target
Study Summary
This phase I trial studies the side effects of vaccine therapy when given together with sargramostim in treating patients with malignant glioma. Vaccines made from survivin peptide may help the body build an effective immune response to kill tumor cells. Colony-stimulating factors, such as sargramostim, may increase the number of white blood cells and platelets found in bone marrow or peripheral blood. Giving vaccine therapy and sargramostim may be a better treatment for malignant glioma.
Primary Outcome
The maximum grade of toxicity for each category of interest will be recorded for each patient and the summary results will be tabulated by category and grade. In addition, descriptive statistics will be utilized to present the toxicity findings in the treatment extension group.
Interventions
- OTHER Laboratory Biomarker Analysis
- BIOLOGICAL Sargramostim
- DRUG Montanide ISA-51/Survivin Peptide Vaccine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 9 participants |
| Start Date | 2012-09-05 |
| Est. Completion | 2014-05-29 |
| Phase | Phase 1 |
What the finished NCT01250470 record still lists
NCT01250470 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 9 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (85% lower).
The record links to 0 conditions, and to 3 interventions - of which Laboratory Biomarker Analysis is the first listed.
NCT01250470 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01250470 about?
NCT01250470 is a clinical study titled "Vaccine Therapy and Sargramostim in Treating Patients With Malignant Glioma". This phase I trial studies the side effects of vaccine therapy when given together with sargramostim in treating patients with malignant glioma. Vaccines made from survivin peptide may help the body build an effective immune response to kill tumor cells. Colony-stimulating factors, such as sargramos...
What is the current status of trial NCT01250470?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 9 participants. The study started on 2012-09-05. Estimated completion is 2014-05-29.
What interventions are being tested in trial NCT01250470?
The interventions under investigation include: Laboratory Biomarker Analysis (OTHER), Sargramostim (BIOLOGICAL), Montanide ISA-51/Survivin Peptide Vaccine (DRUG).
Who is sponsoring clinical trial NCT01250470?
This trial is sponsored by Roswell Park Cancer Institute, which has 365 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01250470's enrollment target sits among peer trials
9 1955th of 2000 higher than 42 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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