Phase II Trial of Ontak With Metastatic Melanoma
The purpose of this study is to determine whether ONTAK is an effective treatment in patients with Stage IV Melanoma
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Trial of ONTAK With Metastatic Melanoma|
- Positive response defined as Clinical Complete Response, Partial Response or Stable disease (persisting for at least 4 weeks) as measure by modified RECIST criteria [ Time Frame: 2 weeks after completion of second cycle ] [ Designated as safety issue: No ]
- Overall Survival [ Time Frame: All cause mortality ] [ Designated as safety issue: No ]
|Study Start Date:||March 2006|
|Study Completion Date:||January 2010|
|Primary Completion Date:||January 2010 (Final data collection date for primary outcome measure)|
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.
Other Name: ONTAK
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.
|United States, Kentucky|
|James Graham Brown Cancer Center, Univ. of Louisville|
|Louisville, Kentucky, United States, 40202|
|Principal Investigator:||Jason Chesney, MD, PhD||University of Louisville|