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

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

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00204607

Enrollment

Registered

2005-09-20

Start date

2004-07-31

Completion date

2007-01-31

Last updated

2007-04-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Malignant Melanoma

Brief summary

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

Detailed 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.

Interventions

BIOLOGICALmRNA

DRUGGM-CSF s.c.

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

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

Design outcomes

Primary

Measure	Time frame
toxicity	—
immune response	—

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026