Immunotherapy With Autologous Dexosomes for Patients With Stage IV Melanoma - Full Text View

Immunotherapy With Autologous Dexosomes for Patients With Stage IV Melanoma

This study has been suspended.

Sponsored by:	Anosys
Information provided by:	Anosys
ClinicalTrials.gov Identifier:	NCT00042497

Purpose

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

Condition	Intervention	Phase
Melanoma	Biological: autologous dexosomes loaded with tumor-specific peptides	Phase II

MedlinePlus related topics:

Cancer Melanoma

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study

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

Further study details as provided by Anosys:

Estimated Enrollment:	60
Study Start Date:	July 2002

Eligibility

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.

Contacts and Locations

No Contacts or Locations Provided

More Information

Study ID Numbers:	AN2002-04
First Received:	July 30, 2002
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00042497
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Neuroectodermal Tumors

Nevus, Pigmented

Neoplasms, Germ Cell and Embryonal

Neuroepithelioma

Nevus

Neuroendocrine Tumors

Melanoma

Additional relevant MeSH terms:

Neoplasms

Neoplasms by Histologic Type

Neoplasms, Nerve Tissue

Nevi and Melanomas

ClinicalTrials.gov processed this record on November 20, 2008