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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00095108
Recruitment Status : Completed
First Posted : November 1, 2004
Last Update Posted : March 9, 2009
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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.

Condition or disease Intervention/treatment Phase
Melanoma Kidney Neoplasms Metastases Drug: Recombinant Human Interleukin-21 Phase 1

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 43 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : May 2004
Actual Primary Completion Date : January 2007
Actual Study Completion Date : January 2007

Primary Outcome Measures :
  1. To determine the maximum tolerated dose (MTD) of rIL-21
  2. To further characterize the safety of rIL-21 at the MTD

Secondary Outcome Measures :
  1. Characterize pharmacokinetics of rIL-21
  2. Evaluate immunogenicity of rIL-21
  3. Identify clinical or biological parameters that may correlate with clinical efficacy
  4. Characterize anti-tumor effect of IL-21

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00095108

United States, Michigan
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States, 48109
United States, Washington
University of Washington/Seattle Cancer Care Alliance
Seattle, Washington, United States, 98109
Sponsors and Collaborators
Study Director: Diana Hausman, MD ZymoGenetics Identifier: NCT00095108     History of Changes
Other Study ID Numbers: 494C10
First Posted: November 1, 2004    Key Record Dates
Last Update Posted: March 9, 2009
Last Verified: March 2009

Keywords provided by ZymoGenetics:
Metastatic Melanoma
Metastatic Renal Cell Carcinoma

Additional relevant MeSH terms:
Kidney Neoplasms
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases