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

May 26, 2009 updated by: ZymoGenetics

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

52

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • University Of Alabama
    • Arizona
      • Scottsdale, Arizona, United States, 85260
        • Premiere Oncology of Arizona
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756
        • Dartmouth-Hitchcock Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Safety profile, including incidence and severity of adverse events
Time Frame: During treatment and 28 days after last dose of rIL-21
During treatment and 28 days after last dose of rIL-21

Secondary Outcome Measures

Outcome Measure
Time Frame
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
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
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
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
Time Frame: rIL-21: During treatment and 15 days after dosing; sorafenib: During treatment and 22 days after dosing
rIL-21: During treatment and 15 days after dosing; sorafenib: During treatment and 22 days after dosing

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ZymoGenetics

Investigators

  • Study Director: Naomi Hunder, MD, ZymoGenetics

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2006

Primary Completion (Actual)

May 1, 2009

Study Completion (Actual)

May 1, 2009

Study Registration Dates

First Submitted

October 16, 2006

First Submitted That Met QC Criteria

October 16, 2006

First Posted (Estimate)

October 18, 2006

Study Record Updates

Last Update Posted (Estimate)

May 27, 2009

Last Update Submitted That Met QC Criteria

May 26, 2009

Last Verified

May 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 494F01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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