Vaccination With Tumor mRNA in Metastatic Melanoma - Fixed Combination Versus Individual Selection of Targeted Antigens

NCT ID: NCT00204516

Last Updated: 2013-01-16

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

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-04-30

Study Completion Date

2012-12-31

Brief Summary

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The purpose of the vaccination protocol is to induce specific immune responses against melanoma associated antigens by intradermal injections of mRNA coding for the corresponding antigen.

Detailed Description

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vaccination protocol to induce clinically specific immune responses against melanoma associated antigens by intradermal injections of mRNA coding for the corresponding antigens. Half of patients is treated with mRNA coding for Melan-A, Mage-A1, Mage-A3, Survivin, GP100 and Tyrosinase. The other half of patients is treated with an individualized selection of mRNAs after analysis of overexpressed melanoma antigens in autologous tumor tissue. GM-CSF is used as an adjuvants. Phase I/II clinical trial to analyse safety and immune responses in stage III/IV melanoma patients.

Conditions

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Malignant Melanoma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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mRNA Vacc

Group Type EXPERIMENTAL

mRNA coding for melanoma associated antigens

Intervention Type BIOLOGICAL

mRNA vaccine s.c. applied weekly

GM-CSF

Intervention Type DRUG

Given s.c. as adjuvant drug one day after vaccine

Interventions

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mRNA coding for melanoma associated antigens

mRNA vaccine s.c. applied weekly

Intervention Type BIOLOGICAL

GM-CSF

Given s.c. as adjuvant drug one day after vaccine

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* malignant melanoma stage III/IV
* fresh frozen tumor tissue available
* informed consent given
* Karnofsky \>= 70%

Exclusion Criteria

* brain metastasis
* parallel chemotherapy
* systemic treatment with glucocorticoids
* other malignancies
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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German Research Foundation

OTHER

Sponsor Role collaborator

University Hospital Tuebingen

OTHER

Sponsor Role lead

Responsible Party

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Thomas Eigentler

Study Coordinator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Claus Garbe, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

University of Tuebingen, Department of Dermatology

Locations

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Department of Dermatology, University of Tuebingen

Tübingen, , Germany

Site Status

Countries

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Germany

Other Identifiers

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RNA-Mel-03

Identifier Type: -

Identifier Source: org_study_id

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