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NCT01536054 · ClinicalTrials.gov registry record · Phase 1
Sirolimus and Vaccine Therapy in Treating Patients With Stage II-IV Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cavity Cancer
A Phase 1 study, sponsored by Roswell Park Cancer Institute.
- Completed
- Registry status
- Phase 1
- Development phase
- 7
- Enrollment target
NCT01536054: Completed Phase 1 study, sponsored by Roswell Park Cancer Institute.
NCT01536054 is a Phase 1 study that has completed, run by Roswell Park Cancer Institute. The registered enrollment target is 7 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (88% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01536054, a Phase 1 study, has completed, sponsored by Roswell Park Cancer Institute.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 7 participants
- Enrollment target
Study Summary
This phase I trial studies the side effects and best dose and schedule of sirolimus when given together with vaccine therapy in treating patients with stage II-IV ovarian epithelial, fallopian tube, or primary peritoneal cavity cancer. Sirolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Vaccines made from a gene-modified virus may help the body build an effective immune response to kill tumor cells. Giving vaccine therapy together with sirolimus may be an effective treatment for ovarian, fallopian tube, or primary peritoneal cancer
Primary Outcome
The toxicity rate will be estimated using a one-sided, 95%, exact binomial confidence interval (Clopper-Pearson). The lower one sided limit will be used.
Interventions
- OTHER laboratory biomarker analysis
- DRUG sirolimus
- BIOLOGICAL sargramostim
- BIOLOGICAL ALVAC(2)-NY-ESO-1 (M)/TRICOM vaccine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 7 participants |
| Start Date | 2012-08-20 |
| Est. Completion | 2015-04-21 |
| Phase | Phase 1 |
What the finished NCT01536054 record still lists
NCT01536054 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 7 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (88% lower).
The record links to 0 conditions, and to 4 interventions - of which laboratory biomarker analysis is the first listed.
NCT01536054 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01536054 about?
NCT01536054 is a clinical study titled "Sirolimus and Vaccine Therapy in Treating Patients With Stage II-IV Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cavity Cancer". This phase I trial studies the side effects and best dose and schedule of sirolimus when given together with vaccine therapy in treating patients with stage II-IV ovarian epithelial, fallopian tube, or primary peritoneal cavity cancer. Sirolimus may stop the growth of tumor cells by blocking some of...
What is the current status of trial NCT01536054?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 7 participants. The study started on 2012-08-20. Estimated completion is 2015-04-21.
What interventions are being tested in trial NCT01536054?
The interventions under investigation include: laboratory biomarker analysis (OTHER), sirolimus (DRUG), sargramostim (BIOLOGICAL), ALVAC(2)-NY-ESO-1 (M)/TRICOM vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT01536054?
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 NCT01536054's enrollment target sits among peer trials
7 1972nd of 2000 higher than 27 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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