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Trial NCT00204516

Resource URI: http://static.linkedct.org/resource/trials/NCT00204516
linkedct:brief_title Vaccination With Tumor mRNA in Metastatic Melanoma - Fixed Combination Versus Individual Selection of Targeted Antigens
linkedct:collaborator_agency <http://static.linkedct.org/resource/collabagency/3084>
linkedct:condition <http://static.linkedct.org/resource/condition/7740>
linkedct: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
linkedct: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 individulized selection of mRNAs after analysis of overexpressed melanoma antigens in autologous tumor tissue. GM-CSF is used as an adjuvans. Phase I/II clinical trial to analyse safety and immune respones in stage III/IV melanoma patients.
linkedct:download_date Information obtained from ClinicalTrials.gov on December 30, 2009
linkedct:eligibility_gender Both
linkedct:eligibility_healthy_volunteers No
linkedct:eligibility_maximum_age 80 Years
linkedct:eligibility_minimum_age 18 Years
linkedct:end_date December 2008
linkedct:enrollment 30 (xsd:int)
linkedct:firstreceived_date September 13, 2005
linkedct:id NCT00204516
rdfs:label Trial NCT00204516
linkedct:lastchanged_date April 18, 2007
linkedct:lead_sponsor_agency University Hospital Tuebingen
linkedct:location <http://static.linkedct.org/resource/location/63039>
linkedct:nct_id NCT00204516
linkedct:number_of_arms 0 (xsd:int)
linkedct:number_of_groups 0 (xsd:int)
linkedct: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
linkedct:org_study_id RNA-Mel-03
linkedct:overall_contact_last_name Claus Garbe, Prof. Dr.
linkedct:overall_contact_phone 07071/2985748
linkedct:overall_official <http://static.linkedct.org/resource/overall_official/10210>
linkedct:overall_status Not yet recruiting
linkedct:oversight <http://static.linkedct.org/resource/oversight/1083>
foaf:page <http://clinicaltrials.gov/show/NCT00204516>
linkedct:phase Phase 1/Phase 2
linkedct:primary_outcomes <http://static.linkedct.org/resource/primary_outcomes/10199>
linkedct:primary_outcomes <http://static.linkedct.org/resource/primary_outcomes/21438>
linkedct:source University Hospital Tuebingen
linkedct:start_date April 2007
linkedct:study_design Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
linkedct:study_type Interventional
linkedct:summary vaccination protocol to induce specific immune responses against melanoma associated antigens by intradermal injections of mRNA coding for the corresponding antigen
rdf:type linkedct:trials
linkedct:verification_date April 2007