At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 69 enrolled
Drug / intervention
Denileukin diftitoxdrug
Likely dose
Denileukin diftitox 12 mcg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Phase II Trial of ONTAK With Metastatic Melanoma
In Brief
A Phase 2 clinical trial evaluating Denileukin diftitox for Malignant Melanoma. Completed, enrolled 69 participants across 1 site.
Detailed Summary
The purpose of this study is to determine whether ONTAK is an effective treatment in patients with Stage IV Melanoma
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMalignant Melanoma
CountriesUnited States
CollaboratorsUniversity of Louisville
Timeline
Phase 2CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartMar 2006
First PostedMar 2006
Primary CompletionJan 2010
TodayJul 2026
First PostedMar 7, 2006
Enrollment StartMar 1, 2006
Primary CompletionJan 1, 2010
TodayJul 2, 2026
Enrollment to primary: 3.8 yearsPosted 20.3 years ago
Interventions
Denileukin diftitoxdrug
12 mcg/kg IV (in vein) over 30 minutes on days 1 through 4 of each 21 day cycle for 4 cycles.