Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00821652 · ClinicalTrials.gov registry record · Phase 1
Randomized, Double Blind, Placebo-controlled Topical Resiquimod Adjuvant for NY-ESO-1 Protein Vaccination
A Phase 1 study, sponsored by Nina Bhardwaj.
- Completed
- Registry status
- Phase 1
- Development phase
- 26
- Enrollment target
NCT00821652 is a Phase 1 study that has completed, run by Nina Bhardwaj. The registered enrollment target is 26 participants.
The verdict
NCT00821652, a Phase 1 study, has completed, sponsored by Nina Bhardwaj.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 26 participants
- Enrollment target
Study Summary
The study is designed to see if a course of injections containing the NY-ESO-1 protein (a tumor antigen, marker expressed by tumors); in combination with an immune stimulant (adjuvant) Montanide, with or without resiquimod (another adjuvant) is well tolerated and safe in patients with surgically resected Stage IIB, IIC, Stage III or Stage IV (AJCC criteria) melanoma, a tumor that expresses NY-ESO-1. In addition, this study is designed to see if the patient's body's defense (immune) system can be boosted (strengthened) by this vaccine and if the addition of resiquimod to the vaccine makes this more likely.
Interventions
- DRUG NY-ESO-1 protein; Montanide ISA®-51 VG; Resiquimod
- DRUG NY-ESO-1 protein; Montanide ISA®-51 VG; Resiquimod/placebo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 26 participants |
| Start Date | 2009-02 |
| Est. Completion | 2014-12 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00821652
The ClinicalTrials.gov registry entry for NCT00821652 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 26 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Nina Bhardwaj, which has 7 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which NY-ESO-1 protein; Montanide ISA®-51 VG; Resiquimod is the first listed.
NCT00821652 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00821652 about?
NCT00821652 is a clinical study titled "Randomized, Double Blind, Placebo-controlled Topical Resiquimod Adjuvant for NY-ESO-1 Protein Vaccination". The study is designed to see if a course of injections containing the NY-ESO-1 protein (a tumor antigen, marker expressed by tumors); in combination with an immune stimulant (adjuvant) Montanide, with or without resiquimod (another adjuvant) is well tolerated and safe in patients with surgically res...
What is the current status of trial NCT00821652?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 26 participants. The study started on 2009-02. Estimated completion is 2014-12.
What interventions are being tested in trial NCT00821652?
The interventions under investigation include: NY-ESO-1 protein; Montanide ISA®-51 VG; Resiquimod (DRUG), NY-ESO-1 protein; Montanide ISA®-51 VG; Resiquimod/placebo (DRUG).
Who is sponsoring clinical trial NCT00821652?
This trial is sponsored by Nina Bhardwaj, which has 7 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.