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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

January 27, 2009
October 25, 2013
January 2009
December 2009   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT00831467 on ClinicalTrials.gov Archive Site
Not Provided
  • 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 ]
Not Provided
Not Provided
 
Safety and Efficacy Trial of a RNActive®-Derived Prostate Cancer Vaccine in Hormone Refractory Disease
Safety and Efficacy Trial of a RNActive®-Derived Prostate Cancer Vaccine in Hormone Refractory Disease

The purpose of this study is to determine the efficacy and safety of a new vaccine in hormone refractory prostate cancer

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.

Interventional
Phase 1
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Hormonal Refractory Prostate Cancer
Biological: CV9103
Over a period of 23 weeks 5 vaccinations with CV9103 will be administered.
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
Intervention: Biological: CV9103
Fotin-Mleczek M, Duchardt KM, Lorenz C, Pfeiffer R, Ojkić-Zrna S, Probst J, Kallen KJ. Messenger RNA-based vaccines with dual activity induce balanced TLR-7 dependent adaptive immune responses and provide antitumor activity. J Immunother. 2011 Jan;34(1):1-15. doi: 10.1097/CJI.0b013e3181f7dbe8.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
48
September 2013
December 2009   (final data collection date for primary outcome measure)

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
Male
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Germany,   Italy
 
NCT00831467
CV-9103-001
Yes
CureVac GmbH
CureVac GmbH
Not Provided
Principal Investigator: Kurt Miller, Professor PMID: 19143027
CureVac GmbH
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP