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NCT Number: NCT00095108

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

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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Key information

Conditions

Melanoma Adenocarcinoma Carcinoma Carcinoma, Renal Cell Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Neoplasms Male Urogenital Diseases Metastases Neoplasm Metastasis Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplastic Processes Neuroectodermal Tumors Neuroendocrine Tumors Nevi and Melanomas Pathologic Processes Pathological Conditions, Signs and Symptoms Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

University of Michigan Comprehensive Cancer Center, Ann Arbor, Michigan, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Recombinant Human Interleukin-21

Drug

Primary outcomes

  1. To determine the maximum tolerated dose (MTD) of rIL-21

  2. To further characterize the safety of rIL-21 at the MTD

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

ZymoGenetics

Industry

Registry information

Official study 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

Important dates

Study start
2004
Primary completion
2007
Study completion
2007
First posted
Nov 1, 2004
Registry last updated
Mar 9, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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