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

NCT ID: NCT00831467

Last Updated: 2018-03-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-01-31
• Study Completion Date: 2013-09-30

Brief Summary

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

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.

Conditions

Hormonal Refractory Prostate Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

CV9103

Intervention Type: BIOLOGICAL

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

Interventions

CV9103

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

Intervention Type: BIOLOGICAL

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

CureVac

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kurt Miller, Professor

Role: PRINCIPAL_INVESTIGATOR

PMID: 19143027

Locations

Universitätsklinikum Aachen, Urologische Klinik

Aachen, , Germany

Charité Universitätsmedizin Berlin, Urologische Klinik u. Hochschulambulanz

Berlin, , Germany

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

Dresden, , Germany

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

Essen, , Germany

Klinikum der JWG-Universität, Klinik für Urologie und Kinderurologie

Frankfurt am Main, , Germany

Universitätsklinikum Freiburg, Abteilung Urologie

Freiburg im Breisgau, , Germany

UKSH Campus Lübeck, Klinik und Poliklinik fur Urologie

Lübeck, , Germany

Johannes-Gutenberg-Universität Mainz, Urologische Klinik und Poliklinik

Mainz, , Germany

Universitätsmedizin Mannheim, Urologische Klinik

Mannheim, , Germany

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

München, , Germany

Klinik für Urologie, Universitätsklinikum Tübingen

Tübingen, , Germany

Fondazione scientifica Istituto San Raffaele

Milan, , Italy

Countries

Germany; Italy

References

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.

Reference Type: DERIVED

PMID: 21150709 (View on PubMed)

Other Identifiers

CV-9103-001

Identifier Type: -

Identifier Source: org_study_id