Back to resultsImmunotherapy With Autologous Dexosomes for Patients With Stage IV Melanoma
Primary Purpose
Melanoma
Status
Suspended
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
autologous dexosomes loaded with tumor-specific peptides
Sponsored by
About this trial
This is an interventional treatment trial for Melanoma
Eligibility 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.
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00042497
Brief Title
Immunotherapy With Autologous Dexosomes for Patients With Stage IV Melanoma
Official Title
A Phase II, Multicenter, Open-Labeled Study of Immunotherapy With Autologous Dexosomes for Patients With Stage IV Melanoma
Study Type
Interventional
2. Study Status
Record Verification Date
September 2002
Overall Recruitment Status
Suspended
Study Start Date
July 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Anosys
4. Oversight
5. Study Description
Brief Summary
The objective is to determine the safety and efficacy of dexosome immunotherapy in patients with Stage IV malignant melanoma
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Melanoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (false)
8. Arms, Groups, and Interventions
Intervention Type
Biological
Intervention Name(s)
autologous dexosomes loaded with tumor-specific peptides
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
12. IPD Sharing Statement
Learn more about this trial
Immunotherapy With Autologous Dexosomes for Patients With Stage IV Melanoma
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