Status:
COMPLETED
Study of Recombinant Interleukin 21 in Combination With Sorafenib for Metastatic Renal Cell Carcinoma
Lead Sponsor:
ZymoGenetics
Conditions:
Carcinoma, Renal Cell
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
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 d...
Eligibility Criteria
Inclusion
- 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)
Exclusion
- 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
Key Trial Info
Start Date :
October 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2009
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT00389285
Start Date
October 1 2006
End Date
May 1 2009
Last Update
May 27 2009
Active Locations (3)
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1
University of Alabama
Birmingham, Alabama, United States, 35294
2
Premiere Oncology of Arizona
Scottsdale, Arizona, United States, 85260
3
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756