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

Primary Purpose

Malignant Melanoma

Status
Completed
Phase
Phase 1
Locations
Germany
Study Type
Interventional
Intervention
mRNA coding for melanoma associated antigens
GM-CSF
Sponsored by
University Hospital Tuebingen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Malignant Melanoma focused on measuring vaccination, mRNA

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Dermatology, University of Tuebingen

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

mRNA Vacc

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
September 13, 2005
Last Updated
January 15, 2013
Sponsor
University Hospital Tuebingen
Collaborators
German Research Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT00204516
Brief Title
Vaccination With Tumor mRNA in Metastatic Melanoma - Fixed Combination Versus Individual Selection of Targeted Antigens
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
April 2007 (undefined)
Primary Completion Date
August 2011 (Actual)
Study Completion Date
December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital Tuebingen
Collaborators
German Research Foundation

4. Oversight

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malignant Melanoma
Keywords
vaccination, mRNA

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
31 (Actual)

8. Arms, Groups, and Interventions

Arm Title
mRNA Vacc
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
mRNA coding for melanoma associated antigens
Intervention Description
mRNA vaccine s.c. applied weekly
Intervention Type
Drug
Intervention Name(s)
GM-CSF
Intervention Description
Given s.c. as adjuvant drug one day after vaccine
Primary Outcome Measure Information:
Title
Tolerability
Description
Side effects will be monitored using CTCAE criteria. Tolerability and toxicity profiles will be calculated.
Time Frame
every 4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
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 Tuebingen
City
Tuebingen
ZIP/Postal Code
72076
Country
Germany

12. IPD Sharing Statement

Learn more about this trial

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

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