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

Melanoma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00095108
• Other study ID #: 494C10
• Status: Completed
• Phase: Phase 1
• First received: October 29, 2004
• Last updated: March 6, 2009
• Start date: May 2004
• Est. completion date: January 2007

Study information

• Verified date: March 2009
• Source: ZymoGenetics
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: January 2007
• Est. primary completion date: January 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Kidney Neoplasms
• Melanoma
• Metastases

Intervention

Drug:
• Recombinant Human Interleukin-21

Locations

Country	Name	City	State
United States	University of Michigan Comprehensive Cancer Center	Ann Arbor	Michigan
United States	University of Washington/Seattle Cancer Care Alliance	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
ZymoGenetics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine the maximum tolerated dose (MTD) of rIL-21
Primary	To further characterize the safety of rIL-21 at the MTD
Secondary	Characterize pharmacokinetics of rIL-21
Secondary	Evaluate immunogenicity of rIL-21
Secondary	Identify clinical or biological parameters that may correlate with clinical efficacy
Secondary	Characterize anti-tumor effect of IL-21