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NCT00204516 Clinical Trial

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

Malignant Melanoma Clinical Trial

Official title:
Pilot Study of Intradermal Vaccination of Melanoma Patients With a Fixed Combination of mRNAs Compared to an Individualized Selection After Analysis of Antigen Expression in Tumor Tissue

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00204516
Other study ID # RNA-Mel-03
Secondary ID
Status Completed
Phase Phase 1/Phase 2
First received September 13, 2005
Last updated January 15, 2013
Start date April 2007
Est. completion date December 2012

Study information
Verified date January 2013
Source University Hospital Tuebingen
Contact n/a
Is FDA regulated No
Health authority Germany: Ethics Commission
Study type Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility
Status Completed
Enrollment 31
Est. completion date December 2012
Est. primary completion date August 2011
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 80 Years
Eligibility 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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Biological:
• mRNA coding for melanoma associated antigens
mRNA vaccine s.c. applied weekly
Drug:
• GM-CSF
Given s.c. as adjuvant drug one day after vaccine

Locations
Country Name City State
Germany Department of Dermatology, University of Tuebingen Tuebingen

Sponsors (2)
Lead Sponsor Collaborator
University Hospital Tuebingen German Research Foundation

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary Tolerability Side effects will be monitored using CTCAE criteria. Tolerability and toxicity profiles will be calculated. every 4 weeks Yes
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