Immunotherapy With Autologous Dexosomes for Patients With Stage IV Melanoma - Tabular View

Tracking Information
First Received Date ^ICMJE	July 30, 2002
Last Updated Date	June 23, 2005
Start Date ^ICMJE	July 2002
Primary Completion Date
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00042497 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	Immunotherapy With Autologous Dexosomes for Patients With Stage IV Melanoma
Official Title ^ICMJE	A Phase II, Multicenter, Open-Labeled Study of Immunotherapy With Autologous Dexosomes for Patients With Stage IV Melanoma
Brief Summary	The objective is to determine the safety and efficacy of dexosome immunotherapy in patients with Stage IV malignant melanoma
Detailed Description
Study Phase	Phase II
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study
Condition ^ICMJE	Melanoma
Intervention ^ICMJE	Biological: autologous dexosomes loaded with tumor-specific peptides
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Suspended
Enrollment ^ICMJE	60
Completion Date
Primary Completion Date
Eligibility Criteria ^ICMJE	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.
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE

Administrative Information
NCT ID ^ICMJE	NCT00042497
Responsible Party
Study ID Numbers ^ICMJE	AN2002-04
Study Sponsor ^ICMJE	Anosys
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	Anosys
Verification Date	September 2002
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP