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Completed

NCT Number: NCT00204516

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

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.

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Key information

Conditions

Malignant Melanoma Melanoma Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Neuroectodermal Tumors Neuroendocrine Tumors Nevi and Melanomas Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Department of Dermatology, University of Tuebingen

Tübingen, 72076, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

mRNA coding for melanoma associated antigens

Biological

mRNA vaccine s.c. applied weekly

GM-CSF

Drug

Given s.c. as adjuvant drug one day after vaccine

Primary outcomes

  1. Tolerability

    Time frame: every 4 weeks

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

Sponsors and collaborators

Lead sponsor

University Hospital Tuebingen

Other

Collaborators

  • German Research Foundation

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2011
Study completion
2012
First posted
Sep 20, 2005
Registry last updated
Jan 16, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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