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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


Phase 1/Phase 2
18 Years
80 Years
Not Enrolling
Both
Malignant Melanoma

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Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Tolerability

Outcome Description:

Side effects will be monitored using CTCAE criteria. Tolerability and toxicity profiles will be calculated.

Outcome Time Frame:

every 4 weeks

Safety Issue:

Yes

Principal Investigator

Claus Garbe, Prof. Dr.

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Tuebingen, Department of Dermatology

Authority:

Germany: Ethics Commission

Study ID:

RNA-Mel-03

NCT ID:

NCT00204516

Start Date:

April 2007

Completion Date:

December 2012

Related Keywords:

  • Malignant Melanoma
  • vaccination
  • mRNA
  • Melanoma

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