Spots Global Cancer Trial Database for Trial of RNActive®-Derived Prostate Cancer Vaccine in Metastatic Castrate-refractory Prostate Cancer
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Trial Identification
Brief Title: Trial of RNActive®-Derived Prostate Cancer Vaccine in Metastatic Castrate-refractory Prostate Cancer
Official Title: A Randomised, Double-blind, Placebo-controlled, Phase I/II Trial of RNActive®-Derived Cancer Vaccine (CV9104) in Asymptomatic or Minimally Symptomatic Patients With Metastatic Castrate-refractory Prostate Cancer
Study ID: NCT01817738
Conditions
Study Description
Brief Summary: The purpose of this study is to determine whether the new RNActive®-derived prostate cancer vaccine CV9104 prolongs survival in patients with asymptomatic or minimally symptomatic metastatic prostate cancer that is castrate resistant.
Detailed Description: The study is the first clinical study with the new prostate cancer vaccine CV9104. This vaccine is composed of 6RNActive®-based compounds, each encoding for an antigen that is overexpressed in prostate cancer compared to healthy tissues. RNActive®-based vaccines are a novel class of vaccines based on messenger RNA. The study is a double-blind randomized placebo-controlled phase I/II trial in men with asymptomatic- minimally symptomatic metastatic castrate-refractory prostate cancer. The phase 1 (safety lead- in) part of the trial has the primary objective to assess the safety of CV9104 and to determine the dose for the randomized phase II part. The primary objective of the phase II part is to compare overall survival in patients treated with CV9104 compared to patients treated with placebo.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: MALE
Healthy Volunteers: No
Locations
Krajská zdravotní, a.s. - Nemocnice Chomutov, o.z.Onkologické oddělení, Chomutov, , Czech Republic
Fakultní nemocnice Olomouc, Urologická klinika, Olomouc, , Czech Republic
Multiscan, a.s, Oddělení klinické a radiační onkologie, Pardubice, , Czech Republic
Thomayerova nemocnice, Urologické oddělení, Praha, , Czech Republic
Krajská zdravotní, a.s. - Masarykova nemocnice Ústí nad Labem, Usti nad Labem, , Czech Republic
Institut Gustave Roussy, Villejuif cedex, , France
Universitätsklinikum Aachen Klinik für Urologie, Aachen, , Germany
Vivantes Klinikum Am Urban Klinik für Urologie, Berlin, , Germany
Medizinisches Zentrum Friedensplatz, Bonn, , Germany
Universitätsklinikum Dresden Klinik und Poliklinik für Urologie, Dresden, , Germany
Chirurgische Universitätsklinik Freiburg Klinik für Urologie, Freiburg, , Germany
Urologikum Hamburg, Hamburg, , Germany
Nationales Zentrum für Tumorerkrankungen Medizinische Onkologie, Heidelberg, , Germany
Urologie am Nordplatz, Leipzig, , Germany
UMM Universitätsmedizin Mannheim, Mannheim, , Germany
Praxis Dr.schulze, Marklleeberg, , Germany
Urologische Klinik und Poliklinik der Technischen Universität München Klinikum Rechts der Isar, Munich, , Germany
Universitätsklinikum Münster Klinik und Poliklinik für Urologie, Münster, , Germany
Studienpraxis für Urologie, Nürtingen, , Germany
Ortenau Klinikum Urologie und Kinderurologie, Offenburg, , Germany
Urologische Klinik Dr. Castingius München, Planegg, , Germany
Universitätsklinik für Urologie, Tübingen, , Germany
Medica Pro Familia Krakow, Krakow, , Poland
Centrum Urologiczne Sp. z o.o., Mysłowice, , Poland
Centralny Szpital Kliniczny MSWiA, Klinika Onkologii I Hematologii, Warsaw, , Poland
Szpital Sw. Elżbiety - Mokotowskie Centrum Medyczne, Warsaw, , Poland
Instytut M. Curie-Skłodowskiej Centrum Onkologii, Warsaw, , Poland
NZOZ Magodent, Centrum Medyczne Ostrobramska, Oncologii Klinicznej i Chemíoterapii, Warsaw, , Poland
Profesorskie Centrum Medyczne OPTIMUM Wrocław, Wroclaw, , Poland
Szpital Uniwersytecki, Katedra i Klinika Urologii i Onkologii Urologicznej, Wroclaw, , Poland
Hospital de Madrid Norte Sanchinarro Centro Integral Oncológico Clara Campal (CIOCC), Madrid, , Spain
Hospital Clínico Virgen de la Victoria Campus Universitario de Teatinos s/n, Malaga, , Spain
Clínica Universitaria de Navarra Departamento de Oncología, Pamplona, , Spain
Complejo Hospitalario Universitario Santiago Departamento de Oncología, Santiago de Compostela, , Spain
Instituto Valenciano de Oncología Unidad de Investigación Clínica, Valencia, , Spain
"Sahlgrenska Universitetssjukhuset Urologmottagningen, Gothenburg, , Sweden
Skånes Universitetssjukhus Malmö Urologmottagningen, Malmö, , Sweden
Karolinska Universitetssjukhuset Solna Urologiska kliniken, Stockholm, , Sweden
Akademiska sjukhuset Urologmottagningen, Uppsala, , Sweden
Universitetssjukhuset Örebro Urologmottagningen, Örebro, , Sweden
Universitätsspital Basel Medizinische Onkologie, Basel, , Switzerland
Kantonsspital Graubünden Department Innere Medizin Hämatologie und Onkologie, Chur, , Switzerland
CHUV Centre Pluridisciplinaire d'Oncologie, Lausanne, , Switzerland
Kantonsspital St. Gallen Department Innere Medizin Hämatologie Medizinische Onkologie, St. Gallen, , Switzerland
Royal Free Hospital, London, , United Kingdom
Nottingham City Hospital Department of Oncology, Nottingham, , United Kingdom
Clatterbridge Cancer Centre, Wirral, Merseyside, , United Kingdom
York Hospital, York, , United Kingdom
Contact Details
Name: Arnulf Stenzl, Prof. Dr.
Affiliation: University Hospital of Tübingen; Dept. of Urology
Role: PRINCIPAL_INVESTIGATOR
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