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NCT01079741 · ClinicalTrials.gov registry record · Phase 1
Safety Study of Adjuvant Vaccine to Treat Melanoma Patients
A Phase 1 study of Melanoma, sponsored by Nina Bhardwaj.
- Completed
- Registry status
- Phase 1
- Development phase
- 34
- Enrollment target
- 1
- Study location
NCT01079741: Completed Phase 1 study of Melanoma, sponsored by Nina Bhardwaj.
NCT01079741 is a Phase 1 study of Melanoma that has completed, run by Nina Bhardwaj. The registered enrollment target is 34 participants, below the 706-participant average among 266 other Melanoma trials with a reported enrollment target (95% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01079741, a Phase 1 study of Melanoma, has completed, sponsored by Nina Bhardwaj.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 34 participants
- Enrollment target
- 1
- Study location
Study Summary
The incidence of melanoma is increasing with an estimated incidence of 59,940 cases and an annual death rate of 8110 in 2007. Although patients diagnosed with early stage disease have an excellent clinical outcome, patients diagnosed with advanced or recurrent disease, continue to have a high mortality rate, even with initial optimal surgical resection. Effective adjuvant strategies are needed to increase the time to progression and to decrease the recurrence rate. Immunotherapy has long been recognized as a potential therapy for melanoma; the goal of adjuvant vaccine therapy is to train the endogenous immune system to recognize and target minimal residual disease.
Primary Outcome
Safety measured by number of Serious Adverse Events per the CTEP v4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) and Dose Limiting Toxicity (DLT).
Conditions Studied
Interventions
- BIOLOGICAL NY-ESO-1 protein; Poly-ICLC; Montanide
Study Locations (1)
New York
- New York University Langone Medical Center - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 34 participants |
| Start Date | 2010-09 |
| Est. Completion | 2013-03-11 |
| Phase | Phase 1 |
What the finished NCT01079741 record still lists
NCT01079741 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 34 participants, a relatively small participant target, below the 706-participant average among 266 other Melanoma trials with a reported enrollment target (95% lower).
The record links to 1 condition, with Melanoma appearing as the primary indexed condition, and to 1 intervention - of which NY-ESO-1 protein; Poly-ICLC; Montanide is the first listed.
NCT01079741 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT01079741 about?
NCT01079741 is a clinical study titled "Safety Study of Adjuvant Vaccine to Treat Melanoma Patients". The incidence of melanoma is increasing with an estimated incidence of 59,940 cases and an annual death rate of 8110 in 2007. Although patients diagnosed with early stage disease have an excellent clinical outcome, patients diagnosed with advanced or recurrent disease, continue to have a high mortal...
What is the current status of trial NCT01079741?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 34 participants. The study started on 2010-09. Estimated completion is 2013-03-11.
What conditions does trial NCT01079741 study?
This clinical trial studies the following conditions: Melanoma.
What interventions are being tested in trial NCT01079741?
The interventions under investigation include: NY-ESO-1 protein; Poly-ICLC; Montanide (BIOLOGICAL).
Who is sponsoring clinical trial NCT01079741?
This trial is sponsored by Nina Bhardwaj, which has 7 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01079741 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Melanoma
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01079741's enrollment target sits among peer trials
34 190th of 266 higher than 76 of 266 other Melanoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Melanoma 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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