ClinicalTrials.gg
Sign In
CompletedNCT00204607Updated Apr 19, 2007

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

A Phase 1/2 interventional study of mRNA and GM-CSF s.c. in Malignant Melanoma, sponsored by University Hospital Tuebingen. Completed at 1 site in Germany. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2007-04-19.

Sponsored by University Hospital Tuebingen · Phase 1/2, Interventional, and Treatment

Phase
Phase 1/2
Study type
Interventional
Enrollment
20
Allocation
Non-randomized
Ages
18 Years to 75 Years
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Malignant Melanoma

Browse trials for

03

In context

Melanoma

3,073 studies on the registry are indexed under Melanoma; 529 are open to participants now.

This study's enrollment of 20 is below the median of 38 across 2,400 interventional studies indexed under Melanoma.

Browse Melanoma studies →

Lead sponsor

University Hospital Tuebingen is the lead sponsor of 490 studies on the registry; 108 are open to participants now.

Browse University Hospital Tuebingen studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • systemic glucocorticoids
  • brain metestasis
  • other malignancies
05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants

Interventions

  • BiologicalmRNA
  • DrugGM-CSF s.c.
06

What researchers measure

Primary outcomes

  1. toxicity

  2. immune response

07

Study locations

1 site
  • Department of Dermatology, University of Tübingen
    Tübingen, 72076, Germany
08

References and documents

Publications

  • 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. PubMed 19609242 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 19, 2007, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00204607
Lead sponsor
University Hospital Tuebingen
First posted
Sep 20, 2005
Start date
Jul 2004
Completion
Jan 2007
Last update
Apr 19, 2007

Study contacts

Claus Garbe, Prof. Dr.
principal investigator · University of Tuebingen, Department of dermatology
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2007. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Melanoma →

Other studies from this sponsor

University Hospital Tuebingen →

Start the discussion