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

Purpose

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

Condition	Intervention	Phase
Malignant Melanoma	Biological: mRNA Drug: GM-CSF s.c.	Phase I Phase II

MedlinePlus related topics:

Cancer Melanoma

ChemIDplus related topics:

Sargramostim Granulocyte-macrophage colony-stimulating factor

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

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

Further study details as provided by University Hospital Tuebingen:

Primary Outcome Measures:

toxicity
immune response

Estimated Enrollment:	20
Study Start Date:	July 2004
Study Completion Date:	January 2007

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.

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00204607

Locations


Germany
	Department of Dermatology, University of Tübingen
	Tübingen, Germany, 72076

Sponsors and Collaborators

University Hospital Tuebingen

Investigators


Principal Investigator:	Claus Garbe, Prof. Dr.	University of Tuebingen, Department of dermatology

More Information

Study ID Numbers:	RNA-Mel-02
First Received:	September 13, 2005
Last Updated:	April 18, 2007
ClinicalTrials.gov Identifier:	NCT00204607
Health Authority:	Germany: Ethics Commission

Study placed in the following topic categories:

Neuroectodermal Tumors

Nevus, Pigmented

Neoplasms, Germ Cell and Embryonal

Neuroepithelioma

Nevus

Neuroendocrine Tumors

Melanoma

Additional relevant MeSH terms:

Neoplasms

Neoplasms by Histologic Type

Neoplasms, Nerve Tissue

Nevi and Melanomas

ClinicalTrials.gov processed this record on October 16, 2008

Sponsored by:	University Hospital Tuebingen
Information provided by:	University Hospital Tuebingen
ClinicalTrials.gov Identifier:	NCT00204607