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

NCT00831467 | Completed Phase 1 DMC

• 1 other identifier: CV-9103-001
• Study Type: interventional
• Target: 48
• Locations: 2 countries
• Sites: 12

Brief Summary

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

Conditions

Hormonal Refractory Prostate Cancer

Keywords

Hormonal refractory prostate cancer; RNA vaccine

Outcome Measures

Primary Outcomes (2)

• Determination of the recommended dose for exploration in the phase II part

  6-9 months

• Assessment of Safety of trial regimen

  2 years

Study Arms (1)

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

Interventions

CV9103 BIOLOGICAL

Over a period of 23 weeks 5 vaccinations with CV9103 will be administered.

CV9103

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• CureVac: lead

Study Sites (12)

Universitätsklinikum Aachen, Urologische Klinik

Aachen, 52074, Germany

Location

Charité Universitätsmedizin Berlin, Urologische Klinik u. Hochschulambulanz

Berlin, 12200, Germany

Location

Universitätsklinikum Carl Gustav Carus der TU Dresden, Klinik und Poliklinik für Urologie

Dresden, 01307, Germany

Location

Universitätsklinikum Essen, Klinik und Poliklinik für Urologie, Uroonkologie und Kinderurologie

Essen, 45122, Germany

Location

Klinikum der JWG-Universität, Klinik für Urologie und Kinderurologie

Frankfurt am Main, 60590, Germany

Location

Universitätsklinikum Freiburg, Abteilung Urologie

Freiburg im Breisgau, 79106, Germany

Location

UKSH Campus Lübeck, Klinik und Poliklinik fur Urologie

Lübeck, 23538, Germany

Location

Johannes-Gutenberg-Universität Mainz, Urologische Klinik und Poliklinik

Mainz, 55131, Germany

Location

Universitätsmedizin Mannheim, Urologische Klinik

Mannheim, 68167, Germany

Location

Klinikum rechts der Isar der TU München, Urologische Klinik und Poliklinik

München, 81675, Germany

Location

Klinik für Urologie, Universitätsklinikum Tübingen

Tübingen, 72076, Germany

Location

Fondazione scientifica Istituto San Raffaele

Milan, 20132, Italy

Location

Related Publications (1)

• Fotin-Mleczek M, Duchardt KM, Lorenz C, Pfeiffer R, Ojkic-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.

  PMID: 21150709 DERIVED

Study Officials

• Kurt Miller, Professor

  PMID: 19143027

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 27, 2009
• First Posted: January 29, 2009
• Study Start: January 1, 2009
• Primary Completion: December 1, 2009
• Study Completion: September 1, 2013
• Last Updated: March 20, 2018

Record last verified: 2018-03

Locations

DE (11); IT (1)