Study of Recombinant Interleukin 21 in Combination With Sorafenib for Metastatic Renal Cell Carcinoma
- Conditions
- Carcinoma, Renal Cell
- Registration Number
- NCT00389285
- Lead Sponsor
- ZymoGenetics
- Brief Summary
The purpose of the study is to evaluate whether recombinant IL-21 used in combination with sorafenib is safe for patients with metastatic renal cell carcinoma (RCC).
- Detailed Description
This is a Phase 1/2 open-label dose-escalation study of rIL-21 given in combination with sorafenib to patients with metastatic RCC. The Phase 1 part of this study will estimate the maximum tolerated dose of rIL-21 given for 1 treatment course (consisting of two 5-day cycles of rIL-21) in combination with a standard dose of sorafenib administered during a 6-week treatment course. Increasing doses of rIL-21 will be studied sequentially in different groups of patients. The Phase 2 part of the study will further evaluate the safety and preliminary antitumor activity of rIL-21 at the dose recommended from Phase 1 in combination with sorafenib. Patients will be evaluated for safety over the course of the study. Disease evaluation (tumor restaging) will be performed during the last week of each 6-week treatment course. Patients with stable disease or better at this evaluation may go on to receive additional treatment courses. Patients may be in the study for 2 to 7 months.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 52
- Diagnosis of RCC of predominantly clear cell histology
- Either no prior treatment or a maximum of 2 prior treatment regimens for metastatic RCC that included no more than 1 treatment regimen targeting the vascular endothelial growth factor (VEGF) pathway (Phase 1 only)
- At least 1 but no more than 2 prior systemic therapies for metastatic RCC that included no more than 1 therapy targeting the VEGF pathway (Phase 2 only)
- Disease measurable per the Response Evaluation Criteria in Solid Tumors (RECIST) (Phase 2 only)
- Presence of acute infection or other significant systemic illness
- Central nervous system involvement by malignancy
- History of other cancer within 5 years
- Previously received rIL-21 or sorafenib
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Safety profile, including incidence and severity of adverse events During treatment and 28 days after last dose of rIL-21
- Secondary Outcome Measures
Name Time Method Objective response rate at recommended dose of rIL-21 Every 6 weeks during treatment and then every 3 months after last dose of rIL-21 until 3 months after median survival is reached Progression-free survival at recommended dose of rIL-21 Every 6 weeks during treatment and then every 3 months after last dose of rIL-21 until 3 months after median survival is reached Pharmacokinetic profiles of rIL-21 and sorafenib rIL-21: During treatment and 15 days after dosing; sorafenib: During treatment and 22 days after dosing
Trial Locations
- Locations (3)
Dartmouth-Hitchcock Medical Center
🇺🇸Lebanon, New Hampshire, United States
University of Alabama
🇺🇸Birmingham, Alabama, United States
Premiere Oncology of Arizona
🇺🇸Scottsdale, Arizona, United States