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Sponsored by: |
CureVac GmbH |
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Information provided by: | CureVac GmbH |
ClinicalTrials.gov Identifier: | NCT00831467 |
The purpose of this study is to determine the efficacy and safety of a new vaccine in hormone refractory prostate cancer
Condition | Intervention | Phase |
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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 |
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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
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Biological: CV9103
CV9103 encodes for 4 prostate specific antigens (PSA, PSMA, PSCA and STEAP) In both the phase I and the phase II parts of this trial, treatment with CV9103 is administered over a period of 23 weeks, in 5 vaccination time points, which are administered in Weeks 1, 3, 7, 15, and 23. Vaccinations will be administered on the same day of the week. At each vaccination time point, each of the 4 drug product components is administered individually on the same day, as 2 intradermal (i.d.) injections of 200 µL each, giving a total of 8 injections, and a total volume of 1.6 mL. CV9103 is applied intradermally into the thigh and upper arm of either side (4 sites in total). For each site two injections are placed per treatment day. Each drug product component is applied in two injections per treatment day, one into the thigh and one into the upper arm of the same body half. The injection for each drug product component is rotated clockwise at different treatment days.
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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.
Ages Eligible for Study: | 18 Years and older |
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)
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:
Germany | |
Charité Universitätsmedizin Berlin | Recruiting |
Berlin, Germany, 12200 | |
Contact: Kurt Miller, Professor +49 30-8445-2575 kurt.miller@charite.de | |
Principal Investigator: Kurt Miller, Professor | |
Klinik und poliklinik fur urologie | Not yet recruiting |
Lübeck, Germany, 23538 | |
Contact: Dieter JOCHAM, Professor +494515004758 Prof.jocham.MUL@t-online.de | |
Principal Investigator: Dieter JOCHAM, Professor | |
Klinik für Urologie | Recruiting |
Tübingen, Germany, 72076 | |
Contact: Arnulf Stenzl, Professor + 4970712986613 urologie@med.uni-tuebingen.de | |
Principal Investigator: Arnulf Stenzl, Professor | |
Italy | |
Fondazione scientifica Istituto San Raffaele | Not yet recruiting |
Milano, Italy, 20132 | |
Contact: Giorgio Parmiani, Pr +39 02 26437440 parmiani.giorgio@hsr.it | |
Principal Investigator: Giorgio Parmiani, Professor |
Principal Investigator: | Kurt Miller, Professor | PMID: 19143027 |
Responsible Party: | CureVac GmbH ( Thomas LANDER: Managing Director and Chief Medical Officer ) |
Study ID Numbers: | CV-9103-001 |
Study First Received: | January 27, 2009 |
Last Updated: | March 10, 2009 |
ClinicalTrials.gov Identifier: | NCT00831467 History of Changes |
Health Authority: | Germany: Regulatory authorities for Serum and vaccines |
Hormonal refractory prostate cancer RNA vaccine |
Prostatic Diseases Genital Neoplasms, Male Urogenital Neoplasms |
Genital Diseases, Male Hormones Prostatic Neoplasms |
Neoplasms Neoplasms by Site Prostatic Diseases Genital Neoplasms, Male |
Urogenital Neoplasms Genital Diseases, Male Prostatic Neoplasms |