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

This study has been completed.
Sponsor:
Collaborator:
German Research Foundation
Information provided by (Responsible Party):
Thomas Eigentler, University Hospital Tuebingen
ClinicalTrials.gov Identifier:
NCT00204516
First received: September 13, 2005
Last updated: January 15, 2013
Last verified: January 2013
  Purpose

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.


Condition Intervention Phase
Malignant Melanoma
Biological: mRNA coding for melanoma associated antigens
Drug: GM-CSF
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:


Further study details as provided by University Hospital Tuebingen:

Primary Outcome Measures:
  • Tolerability [ Time Frame: every 4 weeks ] [ Designated as safety issue: Yes ]
    Side effects will be monitored using CTCAE criteria. Tolerability and toxicity profiles will be calculated.


Enrollment: 31
Study Start Date: April 2007
Study Completion Date: December 2012
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: mRNA Vacc Biological: mRNA coding for melanoma associated antigens
mRNA vaccine s.c. applied weekly
Drug: GM-CSF
Given s.c. as adjuvant drug one day after vaccine

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00204516

Locations
Germany
Department of Dermatology, University of Tuebingen
Tuebingen, Germany, 72076
Sponsors and Collaborators
University Hospital Tuebingen
German Research Foundation
Investigators
Principal Investigator: Claus Garbe, Prof. Dr. University of Tuebingen, Department of Dermatology
  More Information

No publications provided

Responsible Party: Thomas Eigentler, Study Coordinator, University Hospital Tuebingen
ClinicalTrials.gov Identifier: NCT00204516     History of Changes
Other Study ID Numbers: RNA-Mel-03
Study First Received: September 13, 2005
Last Updated: January 15, 2013
Health Authority: Germany: Ethics Commission

Keywords provided by University Hospital Tuebingen:
vaccination
mRNA

Additional relevant MeSH terms:
Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas

ClinicalTrials.gov processed this record on August 19, 2014