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Study of ONTAK in Patients With Stage IIIC and Stage IV Melanoma

2014-08-27 03:13:33 | BioPortfolio

Summary

The purpose of this study is to determine whether Patients with Stage IIIC and Stage IV Melanoma experience benefit when treated with ONTAK in two different dosing schedules.

Description

This will be multicenter, open-label, dose/schedule and clinical efficacy study in patients with Stage IIIC and Stage IV melanoma.

Dose-Schedules :This is a schedule, dose, and pharmacodynamic study of ONTAK in patients with Stage IIIC and Stage IV melanoma. Two arms of 40 patients each are planned (see below) for a total of 80 patients. Patients will be randomly assigned to 1 of 2 arms: 1. 12 mcg/kg/day on Days 1 through 4 of each 21-day treatment cycle, for a total of 4 cycles (12 weeks); 2. 12 mcg/kg/day on Days 1, 8, and 15 of each 21-day treatment cycle, for a total of 4 cycles (12 weeks). Patients will be evaluated for (1) clinical response, (2) safety and tolerability, and (3) pharmacodynamic measures of ONTAK activity. An optional substudy will be conducted that will involve collection of serial tumor biopsies at study entry and Day 84 in order to assess tissue pharmacodynamic markers of ONTAK activity (Treg depletion in tumor, appearance of melanoma antigen-specific CD8+lymphocytes, and other markers of mucosal immunity and inflammatory response).

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Stage IIIC Melanoma

Intervention

ONTAK (denileukin diftitox)

Location

Alta Bates Summit Comprehensive Cancer Center
Berkeley
California
United States
94705

Status

Recruiting

Source

Eisai Inc.

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:13:33-0400

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