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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00389285
Recruitment Status : Completed
First Posted : October 18, 2006
Last Update Posted : May 27, 2009
Information provided by:

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).

Condition or disease Intervention/treatment Phase
Carcinoma, Renal Cell Drug: rIL-21 only Drug: rIL-21 + sorafenib Phase 1 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 52 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1/2, Open-Label, Dose Escalation Study to Assess the Safety and Pharmacokinetics of Recombinant Interleukin 21 (rIL-21) Administered Concomitantly With Sorafenib (Nexavar) in Subjects With Metastatic Renal Cell Carcinoma
Study Start Date : October 2006
Actual Primary Completion Date : May 2009
Actual Study Completion Date : May 2009

Intervention Details:
  • Drug: rIL-21 only
    Part 1: rIL-21, IV, Day 1-5 and 15-19 of each 6-week treatment course
  • Drug: rIL-21 + sorafenib
    Part 2: rIL-21 IV, Day 1-5 and 15-19 of each 6-week treatment course + sorafenib (up to 400 mg taken orally twice daily)

Primary Outcome Measures :
  1. Safety profile, including incidence and severity of adverse events [ Time Frame: During treatment and 28 days after last dose of rIL-21 ]

Secondary Outcome Measures :
  1. Objective response rate at recommended dose of rIL-21 [ Time Frame: Every 6 weeks during treatment and then every 3 months after last dose of rIL-21 until 3 months after median survival is reached ]
  2. Progression-free survival at recommended dose of rIL-21 [ Time Frame: Every 6 weeks during treatment and then every 3 months after last dose of rIL-21 until 3 months after median survival is reached ]
  3. Pharmacokinetic profiles of rIL-21 and sorafenib [ Time Frame: rIL-21: During treatment and 15 days after dosing; sorafenib: During treatment and 22 days after dosing ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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 Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00389285

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United States, Alabama
University of Alabama
Birmingham, Alabama, United States, 35294
United States, Arizona
Premiere Oncology of Arizona
Scottsdale, Arizona, United States, 85260
United States, New Hampshire
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756
Sponsors and Collaborators
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Study Director: Naomi Hunder, MD ZymoGenetics
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Naomi Hunder, Medical Monitor, ZymoGenetics, Inc. Identifier: NCT00389285    
Other Study ID Numbers: 494F01
First Posted: October 18, 2006    Key Record Dates
Last Update Posted: May 27, 2009
Last Verified: May 2009
Keywords provided by ZymoGenetics:
Carcinoma, renal cell
Additional relevant MeSH terms:
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Carcinoma, Renal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action