Conditions: Malignant Melanoma
Keywords: Melanoma Metastatic Stage IV Ontak
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 69
Healthy volunteers: no

Brief 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.

Arms:
arm 1: Single-arm: Ontak

Interventions: intervention 1: Denileukin diftitox
Intervention descriptions: intervention 1: 12 mcg/kg IV (in vein) over 30 minutes on days 1 through 4 of each 21 day cycle for 4 cycles.

Protocol document: