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


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

This study is currently recruiting patients.

Sponsored by:	ZymoGenetics
Information provided by:	ZymoGenetics

Purpose

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.

Condition	Treatment or Intervention	Phase
Melanoma Kidney Neoplasms Metastases	Drug: Recombinant Human Interleukin-21	Phase I

Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

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

Further Study Details:

Primary Outcomes: To determine the maximum tolerated dose (MTD) of rIL-21; To further characterize the safety of rIL-21 at the MTD
Secondary Outcomes: 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

Expected Total Enrollment: 50

Study start: May 2004; Expected completion: March 2006
Last follow-up: December 2005; Data entry closure: January 2006

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.

Eligibility

Ages Eligible for Study: 18 Years and above, Genders Eligible for Study: Both

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

Location and Contact Information

Michigan
University of Michigan Comprehensive Cancer Center, Ann Arbor, Michigan, 48109, United States; Recruiting

Research Information 800-865-1125
Bruce Redman, DO, Principal Investigator

Washington
University of Washington/Seattle Cancer Care Alliance, Seattle, Washington, 98109, United States; Recruiting

Jennifer Revall 206-288-2041
Linda Kirsch 206-288-1195
John Thompson, MD, Principal Investigator

More Information

Study ID Numbers: 494C10
Record last reviewed: October 2004
Record first received: October 29, 2004
ClinicalTrials.gov Identifier: NCT00095108
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2004-11-18

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