The purpose of this study is to determine whether ONTAK is an effective treatment in patients with Stage IV Melanoma
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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
69
12 mcg/kg IV (in vein) over 30 minutes on days 1 through 4 of each 21 day cycle for 4 cycles.
James Graham Brown Cancer Center, Univ. of Louisville
Louisville, Kentucky, United States
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
Overall Survival
Time frame: All cause mortality
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.