Trial Information
A Phase II, Multicenter, Open-Labeled Study of Immunotherapy With Autologous Dexosomes for Patients With Stage IV Melanoma
Inclusion Criteria
- Patients with Stage IV metastatic melanoma with 0-1 prior treatments for metastatic
disease.
- All patients must have distant skin, subcutaneous, or nodal metastases (M1a) or lung
metastases (M1b), measurable disease, normal lactate dehydrogenase levels, and HLA
type A1, A2, or B35.
- Patients must have adequate organ function and an estimated life expectancy of at
least 3 months.
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Authority:
United States: Food and Drug Administration
Study ID:
AN2002-04
NCT ID:
NCT00042497
Start Date:
July 2002
Completion Date:
Related Keywords: