NCT00204607

Brief Summary

vaccination protocol 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
20

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jul 2004

Typical duration 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

Study Start

First participant enrolled

July 1, 2004

Completed
1.2 years until next milestone

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
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2007

Completed
Last Updated

April 19, 2007

Status Verified

April 1, 2007

First QC Date

September 13, 2005

Last Update Submit

April 18, 2007

Conditions

Malignant Melanoma

Outcome Measures

Primary Outcomes (2)

  • toxicity

  • immune response

Interventions

mRNABIOLOGICAL
GM-CSF s.c.DRUG

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • stage III/IV
  • fresh frozen tumor-tissue
  • age 18-75
  • informed consent given
  • Karnofsky \>= 70%

You may not qualify if:

  • systemic glucocorticoids
  • brain metestasis
  • other malignancies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Dermatology, University of Tübingen

Tübingen, 72076, Germany

Location

Related Publications (1)

  • Weide B, Pascolo S, Scheel B, Derhovanessian E, Pflugfelder A, Eigentler TK, Pawelec G, Hoerr I, Rammensee HG, Garbe C. Direct injection of protamine-protected mRNA: results of a phase 1/2 vaccination trial in metastatic melanoma patients. J Immunother. 2009 Jun;32(5):498-507. doi: 10.1097/CJI.0b013e3181a00068.

    PMID: 19609242DERIVED

MeSH Terms

Conditions

Melanoma

Interventions

RNA, Messenger

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)

RNANucleic AcidsNucleic Acids, Nucleotides, and Nucleosides

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

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 20, 2005

Study Start

July 1, 2004

Study Completion

January 1, 2007

Last Updated

April 19, 2007

Record last verified: 2007-04

Locations

DE(1)