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NCT00204607 Clinical Trial

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

Malignant Melanoma Clinical Trial

Official title:
Induction of Specific Immune Responses Against Melanoma-Associated Antigens in Vivo by Intradermal Vaccination With Stabilized Tumor mRNA - a Clinical Phase I/II Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00204607
Other study ID # RNA-Mel-02
Secondary ID
Status Completed
Phase Phase 1/Phase 2
First received September 13, 2005
Last updated April 18, 2007
Start date July 2004
Est. completion date January 2007

Study information
Verified date April 2007
Source University Hospital Tuebingen
Contact n/a
Is FDA regulated No
Health authority Germany: Ethics Commission
Study type Interventional

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility
Status Completed
Enrollment 20
Est. completion date January 2007
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 75 Years
Eligibility 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

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

Drug:
• GM-CSF s.c.

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

Sponsors (1)
Lead Sponsor Collaborator
University Hospital Tuebingen

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary toxicity
Primary immune response
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