Immunotherapy With Autologous Dexosomes for Patients With Stage IV Melanoma

This study has suspended participant recruitment.
Sponsor:
Information provided by:
Anosys
ClinicalTrials.gov Identifier:
NCT00042497
First received: July 30, 2002
Last updated: June 23, 2005
Last verified: September 2002
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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

No publications provided

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

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

ClinicalTrials.gov processed this record on April 17, 2014