Phase II Trial of Ontak With Metastatic Melanoma
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|ClinicalTrials.gov Identifier: NCT00299689|
Recruitment Status : Completed
First Posted : March 7, 2006
Results First Posted : September 5, 2014
Last Update Posted : September 5, 2014
|Condition or disease||Intervention/treatment||Phase|
|Malignant Melanoma||Drug: Denileukin diftitox||Phase 2|
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 (Clinical Trial)|
|Actual Enrollment :||69 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Trial of ONTAK With Metastatic Melanoma|
|Study Start Date :||March 2006|
|Actual Primary Completion Date :||January 2010|
|Actual Study Completion Date :||January 2010|
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
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00299689
|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|