Study of Interleukin-21 for Metastatic Malignant Melanoma and Metastatic Kidney Cancer

Phase 1

Completed

• Conditions: Melanoma; Kidney Neoplasms; Metastases

• Registration Number: NCT00095108
• Lead Sponsor: ZymoGenetics

Brief Summary

This study is being done to see if an experimental drug called recombinant interleukin-21 (rIL-21) when given to patients with stage 4 malignant melanoma or stage 4 kidney cancer is safe and has any effect on these types of cancers.

Detailed Description

This is a phase 1 safety study. Everyone enrolled and eligible will be given rIL-21. The study has 2 parts, Part A will determine how high a dose of rIl-21 can be safely given to patients with these types of cancers. Part B will determine if the drug is of any benefit to patients with these types of cancers. Part A may have up to 7 different dose groups. Beginning with the lowest dose, 3 patients will be treated and will be watched for side effects. If the side effects are not severe, the next group of 3 patients will recieve a higher dose. This cycle is repeated until the highest tolerated dose group is found.

Study Timeline

• Study Start: 2004-05
• Study First Submitted: 2004-10-29
• Study First Submitted QC: 2004-10-29
• Study First Posted: 2004-11-01
• Primary Completion: 2007-01
• Study Completion: 2007-01
• Status Verified: 2009-03
• Last Update Submitted: 2009-03-06
• Last Update Posted: 2009-03-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 43

Inclusion Criteria

• 18 years and older with stage 4 metastatic malignant melanoma or stage 4 metastatic kidney cancer
• ECOG status of 0 or 1
• Patients must have adequate liver, kidney and bone marrow function

Exclusion Criteria

• Known ocular melanoma
• Suspected or confirmed brain metastases
• Patient cannot have had a bone marrow transplant

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
To determine the maximum tolerated dose (MTD) of rIL-21
To further characterize the safety of rIL-21 at the MTD

Secondary Outcome Measures

Name	Time	Method
Characterize pharmacokinetics of rIL-21
Evaluate immunogenicity of rIL-21
Identify clinical or biological parameters that may correlate with clinical efficacy
Characterize anti-tumor effect of IL-21

Trial Locations

Locations (2)

University of Michigan Comprehensive Cancer Center; 🇺🇸 Ann Arbor, Michigan, United States

University of Washington/Seattle Cancer Care Alliance; 🇺🇸 Seattle, Washington, United States