Trial Outcomes & Findings for Phase II Trial of Ontak With Metastatic Melanoma (NCT NCT00299689)

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

69 participants

Primary outcome timeframe

2 weeks after completion of second cycle

Results posted on

2014-09-05

Participant milestones
Measure	Intervention Single-arm: Ontak Denileukin diftitox : 12 mcg/kg IV (in vein) over 30 minutes on days 1 through 4 of each 21 day cycle for 4 cycles.
Overall Study STARTED	69
Overall Study COMPLETED	69
Overall Study NOT COMPLETED	0

Withdrawal data not reported

Phase II Trial of Ontak With Metastatic Melanoma

Baseline characteristics by cohort
Measure	Intervention n=69 Participants Single-arm: Ontak Denileukin diftitox : 12 mcg/kg IV (in vein) over 30 minutes on days 1 through 4 of each 21 day cycle for 4 cycles.
Age, Customized >= 18 years	69 Participants n=99 Participants
Sex: Female, Male Female	24 Participants n=99 Participants
Sex: Female, Male Male	45 Participants n=99 Participants

Timeframe: 2 weeks after completion of second cycle

Outcome measures
Measure	Intervention n=16 Participants Single-arm: Ontak Denileukin diftitox : 12 mcg/kg IV (in vein) over 30 minutes on days 1 through 4 of each 21 day cycle for 4 cycles.
Positive Response Defined as Clinical Complete Response, Partial Response or Stable Disease (Persisting for at Least 4 Weeks) as Measure by Modified RECIST Criteria	16 participants

Timeframe: All cause mortality

Outcome data not reported

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Adverse event data not reported

Adverse event data not reported

James Graham Brown Cancer Center, University of Louisville

Phone: 502/852-3679