Efficacy Study of IL-21 to Treat Metastatic Melanoma

Novo Nordisk

Status and phase: Completed; Phase 2

Conditions: Malignant Melanoma; Cancer

Treatments: Drug: recombinant interleukin-21

Study type: Interventional

Funder types: Industry

Identifiers

NCT00336986

NN028-1614

Details and patient eligibility

About

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.

Enrollment: 54 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)