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Immunotherapy With Autologous Dexosomes for Patients With Stage IV Melanoma

This study has suspended participant recruitment.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00042497
First Posted: August 1, 2002
Last Update Posted: December 9, 2005
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Anosys
  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 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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:


Further study details as provided by Anosys:

Estimated Enrollment: 60
Study Start Date: July 2002
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

ClinicalTrials.gov Identifier: NCT00042497     History of Changes
Other Study ID Numbers: AN2002-04
First Submitted: July 30, 2002
First Posted: August 1, 2002
Last Update Posted: December 9, 2005
Last Verified: September 2002

Additional relevant MeSH terms:
Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas