Effect of Recombinant Interleukin-21 on the Lymph Node Pathology in Patients With Stage III Melanoma.
Phase 2
18 Years
N/A
18 Years
N/A
Not Enrolling
Both
Malignant Melanoma, Cancer
Both
Malignant Melanoma, Cancer
Trial Information
Effect of Recombinant Interleukin-21 on the Lymph Node Pathology in Patients With Stage III Melanoma.
The decision to discontinue the NN028-1801 trial is not due to any safety concerns. The
trial was terminated as a result of a strategic decision by the sponsoring company.
Inclusion Criteria:
- Stage III melanoma
- ECOG performance status 0-1
Exclusion Criteria:
- Signs of stage IV melanoma
- Safety variables
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:
Complete pathological response rate in the lymph nodes
Outcome Time Frame:
after 4 weeks of treatment
Safety Issue:
No
Principal Investigator
Paul Kristjansen, MD, PhD, DMSc
Investigator Role:
Study Director
Investigator Affiliation:
Novo Nordisk
Authority:
Germany: Federal Institute for Drugs and Medical Devices
Study ID:
NN028-1801
NCT ID:
NCT00601861
Start Date:
February 2008
Completion Date:
June 2008
Related Keywords:
- Malignant Melanoma
- Cancer
- Melanoma
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