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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.
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).
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Stage IIIC Melanoma
ONTAK (denileukin diftitox)
Alta Bates Summit Comprehensive Cancer Center
Published on BioPortfolio: 2014-08-27T03:13:33-0400
Primary Objective: 1. To assess the response rate of ONTAK in Systemic Mastocytosis (SM) patients. Secondary Objectives: 1. To assess the safety of ONTAK in SM patients. ...
The purpose of this study is to determine whether ONTAK is an effective treatment in patients with Stage IV Melanoma
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A melanosome-specific protein that plays a role in the expression, stability, trafficking, and processing of GP100 MELANOMA ANTIGEN, which is critical to the formation of Stage II MELANOSOMES. The protein is used as an antigen marker for MELANOMA cells.
An unpigmented malignant melanoma. It is an anaplastic melanoma consisting of cells derived from melanoblasts but not forming melanin. (Dorland, 27th ed; Stedman, 25th ed)
Experimentally induced tumor that produces MELANIN in animals to provide a model for studying human MELANOMA.
A cellular subtype of malignant melanoma. It is a pigmented lesion composed of melanocytes occurring on sun-exposed skin, usually the face and neck. The melanocytes are commonly multinucleated with a "starburst" appearance. It is considered by many to be the in situ phase of lentigo maligna melanoma.
Found in large amounts in the plasma and urine of patients with malignant melanoma. It is therefore used in the diagnosis of melanoma and for the detection of postoperative metastases. Cysteinyldopa is believed to be formed by the rapid enzymatic hydrolysis of 5-S-glutathionedopa found in melanin-producing cells.
Melanoma is a highly malignant tumor of melanin-forming cells (melanocytes) There are most commonly found in the skin (resulting from sunlight exposure), but also in the eyes and mucous membranes. Metastasis to other regions of the body is also common....
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