NCT00204516

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Apr 2007

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 13, 2005

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 20, 2005

Completed
1.5 years until next milestone

Study Start

First participant enrolled

April 1, 2007

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

January 16, 2013

Status Verified

January 1, 2013

Enrollment Period

4.3 years

First QC Date

September 13, 2005

Last Update Submit

January 15, 2013

Conditions

Malignant Melanoma

Keywords

vaccinationmRNA

Outcome Measures

Primary Outcomes (1)

  • Tolerability

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

    every 4 weeks

Study Arms (1)

mRNA Vacc

EXPERIMENTAL
Biological: mRNA coding for melanoma associated antigensDrug: GM-CSF

Interventions

mRNA coding for melanoma associated antigensBIOLOGICAL

mRNA vaccine s.c. applied weekly

mRNA Vacc
GM-CSFDRUG

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

mRNA Vacc

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • malignant melanoma stage III/IV
  • fresh frozen tumor tissue available
  • informed consent given
  • Karnofsky \>= 70%

You may not qualify if:

  • brain metastasis
  • parallel chemotherapy
  • systemic treatment with glucocorticoids
  • other malignancies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Dermatology, University of Tuebingen

Tübingen, 72076, Germany

Location

MeSH Terms

Conditions

Melanoma

Interventions

Granulocyte-Macrophage Colony-Stimulating Factor

Condition Hierarchy (Ancestors)

Neuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Nerve TissueNevi and MelanomasSkin NeoplasmsNeoplasms by SiteSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Colony-Stimulating FactorsGlycoproteinsGlycoconjugatesCarbohydratesHematopoietic Cell Growth FactorsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological Factors

Study Officials

  • Claus Garbe, Prof. Dr.

    University of Tuebingen, Department of Dermatology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Study Coordinator

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 20, 2005

Study Start

April 1, 2007

Primary Completion

August 1, 2011

Study Completion

December 1, 2012

Last Updated

January 16, 2013

Record last verified: 2013-01

Locations

DE(1)