NCT00095108

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
43

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started May 2004

Typical duration for phase_1

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2004

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

October 29, 2004

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 1, 2004

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2007

Completed
Last Updated

March 9, 2009

Status Verified

March 1, 2009

Enrollment Period

2.7 years

First QC Date

October 29, 2004

Last Update Submit

March 6, 2009

Conditions

MelanomaKidney NeoplasmsMetastases

Keywords

Metastatic MelanomaMetastatic Renal Cell Carcinoma

Outcome Measures

Primary Outcomes (2)

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

  • To further characterize the safety of rIL-21 at the MTD

Secondary Outcomes (4)

  • 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

Interventions

Recombinant Human Interleukin-21DRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Known ocular melanoma
  • Suspected or confirmed brain metastases
  • Patient cannot have had a bone marrow transplant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, 48109, United States

Location

University of Washington/Seattle Cancer Care Alliance

Seattle, Washington, 98109, United States

Location

MeSH Terms

Conditions

MelanomaKidney NeoplasmsNeoplasm MetastasisCarcinoma, Renal Cell

Condition Hierarchy (Ancestors)

Neuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Nerve TissueNevi and MelanomasSkin NeoplasmsNeoplasms by SiteSkin DiseasesSkin and Connective Tissue DiseasesUrologic NeoplasmsUrogenital NeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesKidney DiseasesUrologic DiseasesMale Urogenital DiseasesNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and SymptomsAdenocarcinomaCarcinomaNeoplasms, Glandular and Epithelial

Study Officials

  • Diana Hausman, MD

    ZymoGenetics

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

October 29, 2004

First Posted

November 1, 2004

Study Start

May 1, 2004

Primary Completion

January 1, 2007

Study Completion

January 1, 2007

Last Updated

March 9, 2009

Record last verified: 2009-03

Locations

US(2)