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A Phase II, Multicenter, Open-Labeled Study of Immunotherapy With Autologous Dexosomes for Patients With Stage IV Melanoma


Phase 2
18 Years
N/A
Not Enrolling
Both
Melanoma

Thank you

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:

  • Melanoma
  • Melanoma

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