Back to resultsStudy of Interleukin-21 for Metastatic Malignant Melanoma and Metastatic Kidney Cancer
Primary Purpose
Melanoma, Kidney Neoplasms, Metastases
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Recombinant Human Interleukin-21
Sponsored by
About this trial
This is an interventional treatment trial for Melanoma focused on measuring Metastatic Melanoma, Metastatic Renal Cell Carcinoma
Eligibility Criteria
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
Sites / Locations
- University of Michigan Comprehensive Cancer Center
- University of Washington/Seattle Cancer Care Alliance
Outcomes
Primary Outcome Measures
To determine the maximum tolerated dose (MTD) of rIL-21
To further characterize the safety of rIL-21 at the MTD
Secondary Outcome Measures
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00095108
Brief Title
Study of Interleukin-21 for Metastatic Malignant Melanoma and Metastatic Kidney Cancer
Official Title
A Phase 1 Open-Label Study of the Safety and Pharmacokinetics of Recombinant Human Interleukin-21 (rIL-21) in Subjects With Metastatic Melanoma or Metastatic Renal Cell Carcinoma
Study Type
Interventional
2. Study Status
Record Verification Date
March 2009
Overall Recruitment Status
Completed
Study Start Date
May 2004 (undefined)
Primary Completion Date
January 2007 (Actual)
Study Completion Date
January 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
ZymoGenetics
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Melanoma, Kidney Neoplasms, Metastases
Keywords
Metastatic Melanoma, Metastatic Renal Cell Carcinoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
43 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Recombinant Human Interleukin-21
Primary Outcome Measure Information:
Title
To determine the maximum tolerated dose (MTD) of rIL-21
Title
To further characterize the safety of rIL-21 at the MTD
Secondary Outcome Measure Information:
Title
Characterize pharmacokinetics of rIL-21
Title
Evaluate immunogenicity of rIL-21
Title
Identify clinical or biological parameters that may correlate with clinical efficacy
Title
Characterize anti-tumor effect of IL-21
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Diana Hausman, MD
Organizational Affiliation
ZymoGenetics
Official's Role
Study Director
Facility Information:
Facility Name
University of Michigan Comprehensive Cancer Center
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
University of Washington/Seattle Cancer Care Alliance
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Study of Interleukin-21 for Metastatic Malignant Melanoma and Metastatic Kidney Cancer
We'll reach out to this number within 24 hrs