drugset / Trial / NCT00034554

Study of gp75 Vaccine in Patients With Stage III and IV Melanoma

NCT00034554 ↗

Non-randomizedSingle-groupOpen-labelTreatment

Summary

Up to 24 patients with stage III or stage IV melanoma will be enrolled. Patients who are currently disease-free but at high risk for relapse are also eligible. Patients will receive vaccinations of gp75 at assigned dose levels. Patients who exhibit serologic and stable/clinical response are eligible to receive booster vaccinations. Patients will be evaluated for safety and efficacy throughout the duration of the study. In this study, the optimal biologically effective dose is defined as the lowest dose of gp75 that results in the production of anti-gp75 antibodies.

Timeline

Start
2002-03
Primary completion
2004-09
Completion
2004-09

Publications

Drugs

EvaluationDrugModalityDoseRoute
Subject gp75 DNA vaccine Vaccine 0.1 mg Intramuscular
Subject gp75 DNA vaccine Vaccine 0.5 mg Intramuscular
Subject gp75 DNA vaccine Vaccine 2 mg Intramuscular
Subject gp75 DNA vaccine Vaccine 4 mg Intramuscular
Subject gp75 DNA vaccine Vaccine 8 mg Intramuscular

Indications