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| Sponsor: | CureVac GmbH |
|---|---|
| Information provided by: | CureVac GmbH |
| ClinicalTrials.gov Identifier: | NCT00831467 |
Purpose
The purpose of this study is to determine the efficacy and safety of a new vaccine in hormone refractory prostate cancer
| Condition | Intervention | Phase |
|---|---|---|
|
Hormonal Refractory Prostate Cancer |
Biological: CV9103 |
Phase I Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
| Official Title: | Safety and Efficacy Trial of a RNActive®-Derived Prostate Cancer Vaccine in Hormone Refractory Disease |
| Estimated Enrollment: | 30 |
| Study Start Date: | January 2009 |
| Estimated Study Completion Date: | November 2010 |
| Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
CV9103: Experimental
CV9103 is applied intradermally into the thigh and upper arm of either side of the body at week 1, week 3, week 7, week 15, week 23
|
Biological: CV9103
Over a period of 23 weeks 5 vaccinations with CV9103 will be administered.
|
Immunotherapy of prostate cancer is a promising approach for the treatment of advanced or recurrent forms of prostate cancer. Recently, immunotherapy of prostate cancer has been facilitated by the identification of a number of prostate specific antigens that are expressed in healthy and tumor prostate tissues. For prostatectomized patients, such antigens offer ideal targets for immunotherapy as they are only present in tumor but not in healthy tissue. The use of prostate specific antigens in a cancer vaccine is one attractive option for cancer immunotherapy.
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Hormone-refractoriness: Defined by a rise in PSA and/or RECIST-based progression of evaluable lesions, and/or increased number of hotspots on a bone scan, while the patient has a castrated level of testosterone. This castrated level may have been obtained by orchiectomy, or LH-RH analog ± antiandrogen. Antiandrogen must be discontinued for at least 4 weeks before study entry to exclude a withdrawal effect.
Rise in PSA: Defined by a rise in PSA levels at three consecutive time points (PSA rise over nadir, separated by > 1 week, PCWG2 criteria)
Bone marrow function: Hemoglobin ≥ 10 g/dL; Leukocytes ≥ 3000/µL; Lymphocytes ≥ 1000/µL; Absolute neutrophil count ≥ 1500/µL; Platelet count ≥ 100000/µL Hepatic: AST and ALT ≤ 2.5 times upper limit of normal (ULN); Bilirubin ≤ 1.5 ULN Renal: Creatinine ≤ 1.5 mg/dL or creatinine clearance ≥ 60mL/min
Exclusion Criteria:
Contacts and Locations| Contact: Tina HOMRIGHAUSEN | +49 (0) 69-97503 ext 129 | tina.homrighausen@curevac.com |
| Germany | |
| Charité Universitätsmedizin Berlin, Urologische Klinik u. Hochschulambulanz | Recruiting |
| Berlin, Germany, 12200 | |
| Contact: Kurt MILLER, Professor +49 (0) 30-8445-2329 kurt.miller@charite.de | |
| Principal Investigator: Kurt Miller, Professor | |
| UKSH Campus Lübeck, Klinik und Poliklinik fur Urologie | Recruiting |
| Lübeck, Germany, 23538 | |
| Contact: Dieter JOCHAM, Professor +49 (0)451-500 4758 Prof.jocham.MUL@t-online.de | |
| Principal Investigator: Dieter JOCHAM, Professor | |
| Klinik für Urologie, Universitätsklinikum Tübingen | Recruiting |
| Tübingen, Germany, 72076 | |
| Contact: Arnulf STENZL, Professor + 49 (0) 7071-2983228 urologie@med.uni-tuebingen.de | |
| Principal Investigator: Arnulf Stenzl, Professor | |
| Universitätsmedizin Mannheim, Urologische Klinik | Active, not recruiting |
| Mannheim, Germany, 68167 | |
| Klinikum der JWG-Universität, Klinik für Urologie und Kinderurologie | Recruiting |
| Frankfurt Am Main, Germany, 60590 | |
| Contact: Steffen WEDEL, Dr. +49 (0) 69-6301 84778 steffen.wedel@kgu.de | |
| Klinikum rechts der Isar der TU München, Urologische Klinik und Poliklinik | Recruiting |
| München, Germany, 81675 | |
| Contact: Hubert KÜBLER, Dr. +49 (0) 89-4140 6326 h.kuebler@lrz.tum.de | |
| Johannes-Gutenberg-Universität Mainz, Urologische Klinik und Poliklinik | Recruiting |
| Mainz, Germany, 55131 | |
| Contact: Christian HAMPEL, PD Dr. +49 (0) 6131-1723 03 hampel@urologie.klinik.uni-mainz.de | |
| Universitätsklinikum Aachen, Urologische Klinik | Active, not recruiting |
| Aachen, Germany, 52074 | |
| Universitätsklinikum Freiburg, Abteilung Urologie | Recruiting |
| Freiburg, Germany, 79106 | |
| Contact: Wolfgang SCHULTZE-SEEMANN, Prof. Dr. +49 (0) 761-270 2892 wolfgang.schultze-seemann@uniklinik-freiburg.de | |
| Universitätsklinikum Essen, Klinik und Poliklinik für Urologie, Uroonkologie und Kinderurologie | Recruiting |
| Essen, Germany, 45122 | |
| Contact: Frank VOM DORP, Dr. +49 (0) 201-7233 213 frank.vomdorp@uk-essen.de | |
| Universitätsklinikum Carl Gustav Carus der TU Dresden, Klinik und Poliklinik für Urologie | Active, not recruiting |
| Dresden, Germany, 01307 | |
| Italy | |
| Fondazione scientifica Istituto San Raffaele | Recruiting |
| Milano, Italy, 20132 | |
| Contact: Giorgio PARMIANI, Prof. +39 (0) 226437440 parmiani.giorgio@hsr.it | |
| Principal Investigator: Giorgio Parmiani, Professor | |
| Principal Investigator: | Kurt Miller, Professor | PMID: 19143027 |
More Information
| Responsible Party: | CureVac GmbH ( Karl-Josef KALLEN PhD MD: Chief Medical Officer ) |
| Study ID Numbers: | CV-9103-001 |
| Study First Received: | January 27, 2009 |
| Last Updated: | November 12, 2009 |
| ClinicalTrials.gov Identifier: | NCT00831467 History of Changes |
| Health Authority: | Germany: Regulatory authorities for Serum and vaccines |
|
Hormonal refractory prostate cancer RNA vaccine |
|
Neoplasms Neoplasms by Site Prostatic Diseases Genital Neoplasms, Male |
Urogenital Neoplasms Genital Diseases, Male Prostatic Neoplasms |