Immunotherapy With Autologous Dexosomes for Patients With Stage IV Melanoma

Melanoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT00042497
• Other study ID #: AN2002-04
• Status: Suspended
• Phase: Phase 2
• First received: July 30, 2002
• Last updated: June 23, 2005
• Start date: July 2002

Study information

• Verified date: September 2002
• Source: Anosys
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The objective is to determine the safety and efficacy of dexosome immunotherapy in patients with Stage IV malignant melanoma

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 60
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

• 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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Melanoma

Intervention

Biological:
• autologous dexosomes loaded with tumor-specific peptides

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Anosys