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NCT01522820 · ClinicalTrials.gov registry record · Phase 1
Vaccine Therapy With or Without Sirolimus in Treating Patients With NY-ESO-1 Expressing Solid Tumors
A Phase 1 study, sponsored by Roswell Park Cancer Institute.
- Completed
- Registry status
- Phase 1
- Development phase
- 18
- Enrollment target
NCT01522820: Completed Phase 1 study, sponsored by Roswell Park Cancer Institute.
NCT01522820 is a Phase 1 study that has completed, run by Roswell Park Cancer Institute. The registered enrollment target is 18 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (70% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01522820, a Phase 1 study, has completed, sponsored by Roswell Park Cancer Institute.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 18 participants
- Enrollment target
Study Summary
This phase I trial studies the side effects and best schedule of vaccine therapy with or without sirolimus in treating patients with cancer-testis antigen (NY-ESO-1) expressing solid tumors. Biological therapies, such as sirolimus, may stimulate the immune system in different ways and stop tumor cells from growing. Vaccines made from a person's white blood cells mixed with tumor proteins may help the body build an effective immune response to kill tumor cells that express NY-ESO-1. Infusing the vaccine directly into a lymph node may cause a stronger immune response and kill more tumor cells. It is not yet known whether vaccine therapy works better when given with or without sirolimus in treating solid tumors.
Primary Outcome
The safe schedule of the combinatorial regimen is established at the dose before 2/6 patients experience dose-limiting toxicity. Estimated using a one-sided, 95%, exact binomial confidence interval (Clopper-Pearson).
Interventions
- DRUG Sirolimus
- OTHER Laboratory Biomarker Analysis
- OTHER Pharmacological Study
- BIOLOGICAL DEC-205/NY-ESO-1 Fusion Protein CDX-1401
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2012-03 |
| Est. Completion | 2016-07 |
| Phase | Phase 1 |
What the finished NCT01522820 record still lists
NCT01522820 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 18 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (70% lower).
The record links to 0 conditions, and to 4 interventions - of which Sirolimus is the first listed.
NCT01522820 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01522820 about?
NCT01522820 is a clinical study titled "Vaccine Therapy With or Without Sirolimus in Treating Patients With NY-ESO-1 Expressing Solid Tumors". This phase I trial studies the side effects and best schedule of vaccine therapy with or without sirolimus in treating patients with cancer-testis antigen (NY-ESO-1) expressing solid tumors. Biological therapies, such as sirolimus, may stimulate the immune system in different ways and stop tumor cel...
What is the current status of trial NCT01522820?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 18 participants. The study started on 2012-03. Estimated completion is 2016-07.
What interventions are being tested in trial NCT01522820?
The interventions under investigation include: Sirolimus (DRUG), Laboratory Biomarker Analysis (OTHER), Pharmacological Study (OTHER), DEC-205/NY-ESO-1 Fusion Protein CDX-1401 (BIOLOGICAL).
Who is sponsoring clinical trial NCT01522820?
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 NCT01522820's enrollment target sits among peer trials
18 1720th of 2000 higher than 216 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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