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

Phase 2CompletedNCT00204607

University Hospital Tuebingen20 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Malignant Melanoma

Interventions

mRNABIOLOGICAL

GM-CSF s.c.DRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (1)

Department of Dermatology, University of Tübingen

Tübingen, Germany

Outcomes

Primary Outcomes

toxicity

immune response

Data from ClinicalTrials.gov

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