NCT00095108

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 43 (actual)
• Sponsor: ZymoGenetics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Melanoma
• Kidney Neoplasms
• Metastases

Interventions

Type	Name	Description
DRUG	Recombinant Human Interleukin-21

Timeline

• Start date: 2004-05-01
• Primary completion: 2007-01-01
• Completion: 2007-01-01
• First posted: 2004-11-01
• Last updated: 2009-03-09

Locations

2 sites across 1 country: United States