Aldesleukin in Participants With Metastatic Renal Cell Carcinoma or Metastatic Melanoma
Phase 4
Completed
- Conditions
- Metastatic Renal Cell CarcinomaMetastatic Melanoma
- Interventions
- Registration Number
- NCT00414765
- Lead Sponsor
- Novartis Pharmaceuticals
- Brief Summary
This study evaluated the pharmacokinetics of aldesleukin in participants with metastatic renal cell cancer or metastatic melanoma.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 26
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Aldesleukin Aldesleukin All participants were treated with aldesleukin 600,000 international units per kilogram \[IU/kg\] (0.037 milligram (mg)/kg) administered as a 15-minute intravenous (IV) infusion every 8 hours for a maximum of 14 doses for the first cycle (5-day cycle). Following 9 days of rest from therapy, the cycle was repeated for up to 14 doses (i.e., a total of up to 28 doses), if tolerated.
- Primary Outcome Measures
Name Time Method Change in the Area Under the Concentration-Time Curve (AUC) From 0 to 8 Hours (AUC0-8) of Aldesleukin After One Cycle of Therapy From Cycle 1, Day 1 to Cycle 2, Day 15
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (4)
James Graham Brown Cancer Center
🇺🇸Louisville, Kentucky, United States
USC/Kenneth Norris Comprehensive Cancer Center
🇺🇸Los Angeles, California, United States
University of Colorado Cancer Center
🇺🇸Aurora, Colorado, United States
Dartmouth Hitchcock Medical Center
🇺🇸Lebanon, New Hampshire, United States