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

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00095108

Enrollment

Registered

2004-11-01

Start date

2004-05-31

Completion date

2007-01-31

Last updated

2009-03-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Kidney Neoplasms, Melanoma, Metastases

Keywords

Metastatic Melanoma, Metastatic Renal Cell Carcinoma

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.

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.

Interventions

DRUGRecombinant Human Interleukin-21

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
To determine the maximum tolerated dose (MTD) of rIL-21	—
To further characterize the safety of rIL-21 at the MTD	—

Secondary

Measure	Time frame
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	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026