drugset / Trial / NCT00977145

Evaluating the Safety and the Biological Effects of Intratumoral Interferon Gamma and a Peptide-Based Vaccine in Patients With Melanoma

NCT00977145 ↗

Phase 1 Terminated 11 enrolled Craig L Slingluff, Jr
NaSingle-groupOpen-labelTreatment

Summary

The goals of this study are to evaluate 1) the safety of administration of intratumoral interferon gamma with a peptide-based vaccine, in patients with melanoma and 2) the biological effects of the vaccine. These include an examination of changes within the tumor following vaccination and the evaluation of T cell responses to the vaccine both in the blood and at the sight of tumor.

Timeline

Start
2009-11
Primary completion
2012-10
Completion
—

Outcome

Outcome not reported

Stopped (Enrollment): “Closed short of the enrollment goal, due to slow enrollment and adequate data to address endpoints”

Drugs

EvaluationDrugModalityDoseRoute
Subject MELITAC 12.1 Vaccine 100 ug Subcutaneous
Subject MELITAC 12.1 Vaccine 200 ug Subcutaneous
Subject interferon gamma Protein / enzyme biologic 2e+06 iu Other

Indications