Study of Recombinant Interleukin 21 in Combination With Sorafenib for Metastatic Renal Cell Carcinoma

Completed · Phase 1/Phase 2

Conditions studied: Carcinoma, Renal Cell

In brief

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).

Key facts

Study ID

NCT00389285

Run by

ZymoGenetics

People needed

52

Starts

2006-10-01

Expected to finish

2009-05-01

Last updated by the study team

2009-05-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• University of Alabama — Birmingham, Alabama, United States
• Premiere Oncology of Arizona — Scottsdale, Arizona, United States
• Dartmouth-Hitchcock Medical Center — Lebanon, New Hampshire, United States

Full record on ClinicalTrials.gov

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