Safety and Efficacy Trial of a RNActive®-Derived Prostate Cancer Vaccine in Hormone Refractory Disease

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
CureVac GmbH
ClinicalTrials.gov Identifier:
NCT00831467
First received: January 27, 2009
Last updated: October 25, 2013
Last verified: October 2013
  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 1
Phase 2

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

Resource links provided by NLM:


Further study details as provided by CureVac GmbH:

Primary Outcome Measures:
  • Determination of the recommended dose for exploration in the phase II part [ Time Frame: 6-9 months ] [ Designated as safety issue: Yes ]
  • Assessment of Safety of trial regimen [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Enrollment: 48
Study Start Date: January 2009
Study Completion Date: September 2013
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.

Detailed Description:

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
Criteria

Inclusion Criteria:

  • Signed informed consent in accordance with GCP and local regulatory requirements prior to trial participation
  • Male and age ≥ 18 years (Phase I and II) and ≤ 75 years (Phase II only)
  • Histologically confirmed diagnosis of adenocarcinoma of the prostate, Gleason Score available
  • Patients must have been treated with hormonal therapy and may have been treated with surgery and/ or radiation therapy
  • Progressive disease as defined by hormone-refractoriness and rise in PSA:

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)

  • Presence of metastatic disease is acceptable
  • ECOG performance status of 0 to 1
  • Life expectancy > 12 months as assessed by the investigator
  • Adequate organ function :

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

  • Concomitant LH-RH therapy continuation is acceptable
  • May have had local palliative radiotherapy for bone metastasis involving less than 25% of bone marrow
  • Patients requiring bisphosphonates at the time of registration into the trial are eligible (therapy initiated at least 28 days prior to first study treatment administration) and must be continued at a constant level during the study period.
  • Patients of child-producing potential must agree to use contraception while enrolled in the study and for one month after the last immunization.

Exclusion Criteria:

  • Other histologic type of prostate cancer (transitional cell, small cell or squamous cell cancer)
  • Symptomatic brain metastasis or leptomeningeal involvement
  • Patients having received or currently receiving chemo- or biological therapy for prostate cancer
  • Symptomatic congestive heart failure (NYHA 3 and 4); unstable angina pectoris; significant cardiac arrhythmia
  • Pulmonary disease causing dyspnea or fatigue during normal activity
  • History of seizures, encephalitis or multiple sclerosis
  • Inflammatory bowel disease e.g. Crohn's disease or ulcerative colitis; active diverticulitis
  • Documented history of active autoimmune disorders requiring systemic immunosuppressive therapy, (e.g. sarcoidosis, lupus erythematosus, rheumatoid arthritis, glomerulonephritis or systemic vasculitis), excepting autoimmune thyroiditis with only thyroid hormone replacement and stable disease > 1 year
  • Primary or secondary immune deficiency
  • History of allergy requiring medication
  • Active drug abuse or chronic alcoholism
  • Clinically significant active infections
  • Seropositive for HIV, HBV or HCV
  • History of other malignancies over the last 5 years (except basal cell carcinoma of the skin)
  • Uncontrolled medical condition considered as high risk for the treatment with an investigational drug including unstable diabetes mellitus, vena-cava-syndrome, known ascites and/or pleural effusion, symptomatic pleural effusion treated by puncture
  • Renal insufficiency requiring dialysis
  • Patients being committed to an institution by virtue of an order issued either by the judicial or the administrative authorities
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00831467

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
Sponsors and Collaborators
CureVac GmbH
Investigators
Principal Investigator: Kurt Miller, Professor PMID: 19143027
  More Information

No publications provided by CureVac GmbH

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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: October 25, 2013
Health Authority: Germany: Paul-Ehrlich-Institut

Keywords provided by CureVac GmbH:
Hormonal refractory prostate cancer
RNA vaccine

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on September 18, 2014