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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 23, 2014