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NCT00580060 · ClinicalTrials.gov registry record · Early Phase 1
Injection Of AJCC Stage IIB, IIC, III And IV Melanoma Patients With A Multi-Epitope Peptide Vaccine Using GM-CSF DNA As An Adjuvant: A Pilot Trial To Assess Safety And Immunity
A Early Phase 1 study of Melanoma, sponsored by Memorial Sloan Kettering Cancer Center.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 20
- Enrollment target
- 1
- Study location
NCT00580060: Completed Early Phase 1 study of Melanoma, sponsored by Memorial Sloan Kettering Cancer Center.
NCT00580060 is a Early Phase 1 study of Melanoma that has completed, run by Memorial Sloan Kettering Cancer Center. The registered enrollment target is 20 participants, below the 706-participant average among 266 other Melanoma trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00580060, a Early Phase 1 study of Melanoma, has completed, sponsored by Memorial Sloan Kettering Cancer Center.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 20 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a pilot trial to investigate the use of GM-CSF DNA as an adjuvant for peptide vaccination in patients with metastatic melanoma. The objective of this study is to determine the safety and adjuvant effect of vaccination with the gene coding for human GM-CSF with a multi-epitope melanoma peptide vaccine (tyrosinase and gp100 peptides) in patients with AJCC stage IIB, IIC, III and IV melanoma who are HLA-A2+. We will assess whether use of GM-CSF DNA is safe and generates an immune response to peptides derived from antigens on melanoma cells.
Conditions Studied
Interventions
- BIOLOGICAL GM-CSF DNA, NSC 683472 gp100: 209-217(210M), NSC 699048 Tyrosinase: 368-376(370D)
Study Locations (1)
New York
- Memorial Sloan-Kettering Cancer Center - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2003-12 |
| Est. Completion | 2011-06 |
| Phase | Early Phase 1 |
What the finished NCT00580060 record still lists
NCT00580060 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 706-participant average among 266 other Melanoma trials with a reported enrollment target (97% lower).
The record links to 1 condition, with Melanoma appearing as the primary indexed condition, and to 1 intervention - of which GM-CSF DNA, NSC 683472 gp100: 209-217(210M), NSC 699048 Tyrosinase: 368-376(370D) is the first listed.
NCT00580060 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT00580060 about?
NCT00580060 is a clinical study titled "Injection Of AJCC Stage IIB, IIC, III And IV Melanoma Patients With A Multi-Epitope Peptide Vaccine Using GM-CSF DNA As An Adjuvant: A Pilot Trial To Assess Safety And Immunity". This is a pilot trial to investigate the use of GM-CSF DNA as an adjuvant for peptide vaccination in patients with metastatic melanoma. The objective of this study is to determine the safety and adjuvant effect of vaccination with the gene coding for human GM-CSF with a multi-epitope melanoma peptid...
What is the current status of trial NCT00580060?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 20 participants. The study started on 2003-12. Estimated completion is 2011-06.
What conditions does trial NCT00580060 study?
This clinical trial studies the following conditions: Melanoma.
What interventions are being tested in trial NCT00580060?
The interventions under investigation include: GM-CSF DNA, NSC 683472 gp100: 209-217(210M), NSC 699048 Tyrosinase: 368-376(370D) (BIOLOGICAL).
Who is sponsoring clinical trial NCT00580060?
This trial is sponsored by Memorial Sloan Kettering Cancer Center, which has 1,884 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00580060 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
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Where NCT00580060's enrollment target sits among peer trials
20 229th of 266 higher than 36 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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