Phase II Trial of Ontak With Metastatic Melanoma

Status Completed

Clinical Trial Summary

The purpose of this study is to determine whether ONTAK is an effective treatment in patients with Stage IV Melanoma

Clinical Trial Description

This is a Phase II clinical trial to determine whether administration of ONTAK will result in a significant response rate in patients with metastatic melanoma.

Although the development of effective immunotherapy and the characterization of multiagent chemotherapy regimens have substantially improved in the treatment of metastatic malignant melanoma, the overall results remain dismal with a 6% five year survival rate for stage IV disease. Of the common adult-onset cancers, melanoma is widely held to be the most amenable to immunological intervention.

The primary objective of this study is to determine the response rate and the overall survival of patients with metastatic malignant melanoma treated with two regimens of ONTAK. ;

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00299689
Study type	Interventional
Source	James Graham Brown Cancer Center
Contact
Status	Completed
Phase	Phase 2
Start date	March 2006
Completion date	January 2010

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