Phase II Trial of Ontak With Metastatic Melanoma
- Registration Number
- NCT00299689
- Lead Sponsor
- James Graham Brown Cancer Center
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 69
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Intervention Denileukin diftitox Single-arm: Ontak
- Primary Outcome Measures
Name Time Method Positive Response Defined as Clinical Complete Response, Partial Response or Stable Disease (Persisting for at Least 4 Weeks) as Measure by Modified RECIST Criteria 2 weeks after completion of second cycle
- Secondary Outcome Measures
Name Time Method Overall Survival All cause mortality
Trial Locations
- Locations (1)
James Graham Brown Cancer Center, Univ. of Louisville
🇺🇸Louisville, Kentucky, United States