Brief Summary

This trial is conducted in Oceania. A phase 2a study to assess the effect on tumor size. At least 14 to a maximum of 40 patients, who have not previously received treatment for their stage IV disease, will be treated for 6 weeks. IL-21 will be administered intravenously.

Trial Health

On Track

Trial Health Score

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

Enrollment

participants targeted

Target at P50-P75 for phase_2 cancer

Timeline

Completed

Started Sep 2004

Geographic Reach

1 country

7 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

3.1 years study duration

Study Start

First participant enrolled

September 1, 2004

Completed

1.8 years until next milestone

First Submitted

Initial submission to the registry

June 14, 2006

Completed

1 day until next milestone

First Posted

Study publicly available on registry

June 15, 2006

Completed

1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2007

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2007

Completed

Last Updated

August 14, 2023

Status Verified

August 1, 2023

Enrollment Period

3.1 years

First QC Date

June 14, 2006

Last Update Submit

August 10, 2023

Conditions

Cancer Malignant Melanoma

Outcome Measures

Primary Outcomes (1)

Tumor size assessed according to international criteria
After 8 weeks

Secondary Outcomes (4)

Serum levels of antibodies against recombinant human IL-21.
Markers of immunomodulation in blood.
Safety evaluation.
Time to progression.

Interventions

recombinant interleukin-21DRUG

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Histologically confirmed surgically incurable metastatic melanoma
Patients must have measurable disease
ECOG performance status of 0 or 1
Expected life expectancy at least 4 months

You may not qualify if:

History of and signs/symptoms of uncontrolled brain metastases or edema.
Previous treatment with chemotherapy or any biological anti-cancer drug (prior adjuvant therapy with interferon-alpha is permitted as long as treatment was completed at least six months prior to study entry.)
Radiotherapy: Radiation therapy within 4 weeks prior to entering the study.
Receipt of any investigational drug for treatment of metastatic melanoma prior to this trial.

Contact the study team to confirm eligibility.