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

University Hospital Tuebingen

Status and phase: Completed; Phase 2; Phase 1

Conditions: Malignant Melanoma

Treatments: Biological: mRNA coding for melanoma associated antigens; Drug: GM-CSF

Study type: Interventional

Funder types: Other

Identifiers

NCT00204516

RNA-Mel-03

Details and patient eligibility

About

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.

Full 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.

Enrollment: 31 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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31 participants in 1 patient group

mRNA Vacc

Experimental group

Treatment:

Biological: mRNA coding for melanoma associated antigens

Drug: GM-CSF