Trial Information
Phase 2a Study of IL-21 Assessing Tumour Size in Patients With Stage IV Malignant Melanoma
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.
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Tumor size assessed according to international criteria
Outcome Time Frame:
After 8 weeks
Safety Issue:
No
Principal Investigator
Birte K. Skrumsager, MSc
Investigator Role:
Study Director
Investigator Affiliation:
Novo Nordisk
Authority:
Australia: Department of Health and Ageing Therapeutic Goods Administration
Study ID:
NN028-1614
NCT ID:
NCT00336986
Start Date:
September 2004
Completion Date:
October 2007
Related Keywords:
- Malignant Melanoma
- Cancer
- Melanoma