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Safety and Efficacy Trial of a RNActive®-Derived Prostate Cancer Vaccine in Hormone Refractory Disease
This study is currently recruiting participants.
Verified by CureVac GmbH, March 2009
First Received: January 27, 2009   Last Updated: March 10, 2009   History of Changes
Sponsored by: 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

MedlinePlus related topics: Cancer Prostate Cancer
U.S. FDA Resources
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

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 ]

Secondary Outcome Measures:
  • Assessment of safety of the trial regimen [ Time Frame: 6-9 months ] [ Designated as safety issue: Yes ]
  • evaluation of induction of immune response [ Time Frame: 2 Years ] [ Designated as safety issue: No ]
  • Evaluation of the induction of immune response [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Assessment of anti-tumor activity [ Time Frame: 2 years ] [ Designated as safety issue: No ]

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
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.

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 and older
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
  • 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)

  • 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 receiving systemic anticancer therapy
  • 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 or carcinoma in situ of the bladder)
  • 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00831467

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

No publications provided

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

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

Study placed in the following topic categories:
Prostatic Diseases
Genital Neoplasms, Male
Urogenital Neoplasms
Genital Diseases, Male
Hormones
Prostatic Neoplasms

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

ClinicalTrials.gov processed this record on May 06, 2009