NCT00299689

Phase II Trial of Ontak With Metastatic Melanoma

Phase II Trial of ONTAK With Metastatic Melanoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 69 (actual)
• Sponsor: James Graham Brown Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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.

Conditions

• Malignant Melanoma

Interventions

Type	Name	Description
DRUG	Denileukin diftitox	12 mcg/kg IV (in vein) over 30 minutes on days 1 through 4 of each 21 day cycle for 4 cycles.

Timeline

• Start date: 2006-03-01
• Primary completion: 2010-01-01
• Completion: 2010-01-01
• First posted: 2006-03-07
• Last updated: 2014-09-05
• Results posted: 2014-09-05

Locations

1 site across 1 country: United States