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| Sponsor: | CureVac GmbH |
|---|---|
| Information provided by (Responsible Party): | 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: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| 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: | December 2012 |
| Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: CV9103
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| Germany | |
| Universitätsklinikum Aachen, Urologische Klinik | |
| Aachen, Germany, 52074 | |
| Charité Universitätsmedizin Berlin, Urologische Klinik u. Hochschulambulanz | |
| Berlin, Germany, 12200 | |
| Universitätsklinikum Carl Gustav Carus der TU Dresden, Klinik und Poliklinik für Urologie | |
| Dresden, Germany, 01307 | |
| Universitätsklinikum Essen, Klinik und Poliklinik für Urologie, Uroonkologie und Kinderurologie | |
| Essen, Germany, 45122 | |
| Klinikum der JWG-Universität, Klinik für Urologie und Kinderurologie | |
| Frankfurt am Main, Germany, 60590 | |
| Universitätsklinikum Freiburg, Abteilung Urologie | |
| Freiburg, Germany, 79106 | |
| UKSH Campus Lübeck, Klinik und Poliklinik fur Urologie | |
| Lübeck, Germany, 23538 | |
| Johannes-Gutenberg-Universität Mainz, Urologische Klinik und Poliklinik | |
| Mainz, Germany, 55131 | |
| Universitätsmedizin Mannheim, Urologische Klinik | |
| Mannheim, Germany, 68167 | |
| Klinikum rechts der Isar der TU München, Urologische Klinik und Poliklinik | |
| München, Germany, 81675 | |
| Klinik für Urologie, Universitätsklinikum Tübingen | |
| Tübingen, Germany, 72076 | |
| Italy | |
| Fondazione scientifica Istituto San Raffaele | |
| Milano, Italy, 20132 | |
| Principal Investigator: | Kurt Miller, Professor | PMID: 19143027 |
More Information
| Responsible Party: | CureVac GmbH |
| ClinicalTrials.gov Identifier: | NCT00831467 History of Changes |
| Other Study ID Numbers: | CV-9103-001 |
| Study First Received: | January 27, 2009 |
| Last Updated: | January 11, 2012 |
| Health Authority: | Germany: Paul-Ehrlich-Institut |
|
Hormonal refractory prostate cancer RNA vaccine |
|
Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site Neoplasms Genital Diseases, Male |
Prostatic Diseases Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Pharmacologic Actions |