Back to resultsIntradermal Vaccination With Stabilized Tumor mRNA - a Clinical Phase I/II Trial in Melanoma Patients
Primary Purpose
Malignant Melanoma
Status
Completed
Phase
Phase 1
Locations
Germany
Study Type
Interventional
Intervention
mRNA
GM-CSF s.c.
Sponsored by
About this trial
This is an interventional treatment trial for Malignant Melanoma
Eligibility Criteria
Inclusion Criteria: stage III/IV fresh frozen tumor-tissue age 18-75 informed consent given Karnofsky >= 70% Exclusion Criteria: systemic glucocorticoids brain metestasis other malignancies
Sites / Locations
- Department of Dermatology, University of Tübingen
Outcomes
Primary Outcome Measures
toxicity
immune response
Secondary Outcome Measures
Full Information
NCT ID
NCT00204607
First Posted
September 13, 2005
Last Updated
April 18, 2007
Sponsor
University Hospital Tuebingen
1. Study Identification
Unique Protocol Identification Number
NCT00204607
Brief Title
Intradermal Vaccination With Stabilized Tumor mRNA - a Clinical Phase I/II Trial in Melanoma Patients
Official Title
Induction of Specific Immune Responses Against Melanoma-Associated Antigens in Vivo by Intradermal Vaccination With Stabilized Tumor mRNA - a Clinical Phase I/II Trial
Study Type
Interventional
2. Study Status
Record Verification Date
April 2007
Overall Recruitment Status
Completed
Study Start Date
July 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
January 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University Hospital Tuebingen
4. Oversight
5. Study Description
Brief Summary
vaccination protocol to induce specific immune responses against melanoma associated antigens by intradermal injections of mRNA coding for the corresponding antigen
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malignant Melanoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (false)
8. Arms, Groups, and Interventions
Intervention Type
Biological
Intervention Name(s)
mRNA
Intervention Type
Drug
Intervention Name(s)
GM-CSF s.c.
Primary Outcome Measure Information:
Title
toxicity
Title
immune response
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
stage III/IV
fresh frozen tumor-tissue
age 18-75
informed consent given
Karnofsky >= 70%
Exclusion Criteria:
systemic glucocorticoids
brain metestasis
other malignancies
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Claus Garbe, Prof. Dr.
Organizational Affiliation
University of Tuebingen, Department of dermatology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Dermatology, University of Tübingen
City
Tübingen
ZIP/Postal Code
72076
Country
Germany
12. IPD Sharing Statement
Citations:
PubMed Identifier
19609242
Citation
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.
Results Reference
derived
Learn more about this trial
Intradermal Vaccination With Stabilized Tumor mRNA - a Clinical Phase I/II Trial in Melanoma Patients
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