Immunotherapy With Autologous Dexosomes for Patients With Stage IV Melanoma

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. Identifier: NCT00042497
Recruitment Status : Suspended
First Posted : August 1, 2002
Last Update Posted : June 24, 2005
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Brief Summary:
The objective is to determine the safety and efficacy of dexosome immunotherapy in patients with Stage IV malignant melanoma

Condition or disease Intervention/treatment Phase
Melanoma Biological: autologous dexosomes loaded with tumor-specific peptides Phase 2

Study Type : Interventional  (Clinical Trial)
Enrollment : 60 participants
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
Study Start Date : July 2002

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Melanoma
U.S. FDA Resources

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
  • 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. Identifier: NCT00042497     History of Changes
Other Study ID Numbers: AN2002-04
First Posted: August 1, 2002    Key Record Dates
Last Update Posted: June 24, 2005
Last Verified: September 2002

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