Efficacy Study of IL-21 to Treat Metastatic Melanoma

• Status: Completed
• Trial end date: 2007-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novo Nordisk A/S

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.