Intradermal Vaccination With Stabilized Tumor mRNA - a Clinical Phase I/II Trial in Melanoma Patients

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

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-07-31

Study Completion Date

2007-01-31

Brief Summary

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vaccination protocol 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 specific immune responses against melanoma associated antigens by intradermal injections of mRNA coding for the corresponding antigen. Antigens used are Melan-A, Mage-A1, Mage-A3, Survivin, GP100 and Tyrosinase. GM-CSF is used as an adjuvans. Phase I/II clinical trial to analyse safety and immune respones 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

Interventions

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mRNA

Intervention Type BIOLOGICAL

GM-CSF s.c.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* stage III/IV
* fresh frozen tumor-tissue
* age 18-75
* informed consent given
* Karnofsky \>= 70%

Exclusion Criteria

* systemic glucocorticoids
* brain metestasis
* other malignancies

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

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 Tübingen

Tübingen, , Germany

Site Status

Countries

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Germany

References

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Weide B, Pascolo S, Scheel B, Derhovanessian E, Pflugfelder A, Eigentler TK, Pawelec G, Hoerr I, Rammensee HG, Garbe C. Direct injection of protamine-protected mRNA: results of a phase 1/2 vaccination trial in metastatic melanoma patients. J Immunother. 2009 Jun;32(5):498-507. doi: 10.1097/CJI.0b013e3181a00068.

Reference Type DERIVED

PMID: 19609242 (View on PubMed)

Other Identifiers

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RNA-Mel-02

Identifier Type: -

Identifier Source: org_study_id