Immunotherapy With Autologous Dexosomes for Patients With Stage IV Melanoma

NCT00042497 | Suspended Phase 2

• 1 other identifier: AN2002-04
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Melanoma

Interventions

autologous dexosomes loaded with tumor-specific peptides BIOLOGICAL

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

* 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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Anosys: lead

MeSH Terms

Conditions

Melanoma

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: July 30, 2002
• First Posted: August 1, 2002
• Study Start: July 1, 2002
• Last Updated: June 24, 2005

Record last verified: 2002-09