Immunotherapy With Autologous Dexosomes for Patients With Stage IV Melanoma
Sponsor
Anosys (Industry)
Overall Status
Suspended
CT.gov ID
NCT00042497
Collaborator
(none)
60
Study Details
Study Description
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 |
|---|---|---|
|
Phase 2 |
Study Design
Study Type:
Interventional
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
:
Jul 1, 2002
Outcome Measures
Primary Outcome Measures
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
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.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Anosys
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
,
,
ClinicalTrials.gov Identifier:
NCT00042497
Other Study ID Numbers:
- AN2002-04
First Posted:
Aug 1, 2002
Last Update Posted:
Jun 24, 2005
Last Verified:
Sep 1, 2002
Additional relevant MeSH terms: