Efficacy Study of IL-21 to Treat Metastatic Melanoma
Phase 2
Completed
- Conditions
- CancerMalignant Melanoma
- Registration Number
- NCT00336986
- Lead Sponsor
- Novo Nordisk A/S
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 54
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Tumor size assessed according to international criteria After 8 weeks
- Secondary Outcome Measures
Name Time Method Safety evaluation. Serum levels of antibodies against recombinant human IL-21. Markers of immunomodulation in blood. Time to progression.
Trial Locations
- Locations (1)
Novo Nordisk Investigational Site
🇦🇺Westmead, Australia