Immunotherapy With Autologous Dexosomes for Patients With Stage IV Melanoma

NCT ID: NCT00042497

Last Updated: 2005-06-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

SUSPENDED

Clinical Phase

PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-07-31

Brief Summary

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The objective is to determine the safety and efficacy of dexosome immunotherapy in patients with Stage IV malignant melanoma

Detailed Description

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Conditions

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Melanoma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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autologous dexosomes loaded with tumor-specific peptides

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Anosys

INDUSTRY

Sponsor Role lead

Other Identifiers

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AN2002-04

Identifier Type: -

Identifier Source: org_study_id