Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

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 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.

View on ClinicalTrials.gov ↗

View your shortlist →

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

FieldValue
Enrollment Target 20 participants
Start Date 2003-12
Est. Completion 2011-06
Phase Early Phase 1

Sponsor

Memorial Sloan Kettering Cancer Center

1,884 total trials

What the Registry Record Tells You About NCT00580060

The ClinicalTrials.gov registry entry for NCT00580060 describes a study currently listed as completed, categorized as Early Phase 1. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 706-participant average among 266 other Melanoma trials with a reported enrollment target (97% lower). The listed sponsor is Memorial Sloan Kettering Cancer Center, which has 1,884 total studies on file at ClinicalTrials.gov.

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 1 study location spanning 1 distinct geographic area - top geographies include 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.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

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.