Melanoma Clinical Trial

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

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.

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Full 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.

View Eligibility Criteria

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

Study is for people with:

Melanoma

Phase:

Phase 1

Estimated Enrollment:

43

Study ID:

NCT00095108

Recruitment Status:

Completed

Sponsor:

ZymoGenetics

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There are 2 Locations for this study

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University of Michigan Comprehensive Cancer Center
Ann Arbor Michigan, 48109, United States
University of Washington/Seattle Cancer Care Alliance
Seattle Washington, 98109, United States

How clear is this clinincal trial information?

Study is for people with:

Melanoma

Phase:

Phase 1

Estimated Enrollment:

43

Study ID:

NCT00095108

Recruitment Status:

Completed

Sponsor:


ZymoGenetics

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