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

University Hospital Tuebingen

Status and phase: Completed; Phase 2; Phase 1

Conditions: Malignant Melanoma

Treatments: Drug: GM-CSF s.c.; Biological: mRNA

Study type: Interventional

Funder types: Other

Identifiers

NCT00204607

RNA-Mel-02

Details and patient eligibility

About

vaccination protocol 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 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.

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)