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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

43 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-05-31

Study Completion Date

2007-01-31

Brief Summary

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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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Detailed Description

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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

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Melanoma Kidney Neoplasms Metastases

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Recombinant Human Interleukin-21

Intervention Type DRUG

Eligibility Criteria

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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