Immunotherapy With Autologous Dexosomes for Patients With Stage IV Melanoma

This study has been suspended.

First Received: July 30, 2002 Last Updated: June 23, 2005 History of Changes

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

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

Resource links provided by NLM:

MedlinePlus related topics: Cancer 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

No publications provided

Study ID Numbers:	AN2002-04
Study First Received:	July 30, 2002
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00042497 History of Changes
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:

Neuroectodermal Tumors
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Germ Cell and Embryonal

Neoplasms, Nerve Tissue
Nevi and Melanomas
Neuroendocrine Tumors
Melanoma

ClinicalTrials.gov processed this record on July 02, 2009