Localized prostate cancer MedDRA version: 19.0 Level: PT Classification code 10060862 Term: Prostate cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Sponsors
SOTIO a.s.
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: Inc-1) Signed informed consent to the study Inc-2)Patients who were eligible and enrolled to Study SP003, received 10 doses of active cellular immunotherapy in Study SP003 and were without objective progression of the disease since the start of their participation in Study SP003 Inc-3) Time from the last dose of first-cycle active cellular immunotherapy of study SP003 is not longer than 16 weeks at the time of screening Inc-4) The following laboratory values: WBC > 4 x 10(9)/L, platelet count > 100 x 10(9)/L, Hct > 30%, creatinine under 1.5 times the upper limit of normal, bilirubin, AST and ALT under two times the upper limit of normal. Inc-5) ECOG 0-2 Performance Status Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 10 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 14
Exclusion criteria
Exclusion criteria: E-1) Sexually active fertile men not using effective birth control, if their female partners are of fertile age and of child-bearing potential E-2) Comorbidities of the patient: E-2a) HIV positivity E-2b) Active hepatitis B or C E-2c) Active bacterial, viral or fungal infection requiring systemic treatment E-2d) Clinically significant cardiovascular disease (including myocardial infarction or ventricular tachyarrhythmia within last 6 months, percutaneous coronary intervention or surgical revascularization in the past 6 months, heart failure NYHA II-IV, known left ventricular dysfunction with ejection fraction < 40% or haemodynamically significant arrhythmias or conduction disorders) unless secured with permanent cardiac pacing. E-2e) Pleural or pericardial effusion of any CTC grade E-2f) Peripheral neuropathy CTC Grade = 2 E-2g) Other uncontrolled intercurrent condition, uncompensated psychiatric illness or social situation that would limit patient’s compliance E-2h) Patients with a history of malignancy other than non-melanoma skin cancer E-2i) Unresolved clinically significant urinary tract obstruction E-2j) Active autoimmune disease requiring therapy E-2k) History of primary immunodeficiency E-3) Allergies and adverse drug reactions E-3a) History of allergic reaction to a compound of the same or similar structure as the investigational medicinal product E-3b) History of anaphylaxis or other severe reaction following vaccination E-4) Any other serious reason the Investigator considers the patient should not participate in the study E-5) Any prostate cancer N and M stage other than N0 and M0 E-6) History of or ongoing androgen deprivation therapy after radical prostatectomy E-7) History of or ongoing chemotherapy for prostate cancer E-8) Immunotherapy other than specified in this protocol E-9) Forbidden concomitant medication (other investigational drugs, products or instruments, any anti-tumour androgen deprivation therapy, bisphosphonate treatment) E-10) Indication for radiotherapy during Study SP003 or screening period for Study SP010
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The clinical trial’s objective is to establish the safety profile of extended application of active cellular immunotherapy (ACI) prepared from repeated leukapheresis. The safety of the second cycle of active cellular immunotherapy involving second leukapheresis will be assessed in patients, who successfully received all doses of active cellular immunotherapy (ACI) in Study SP003, and who were without objective progression of the disease during Study SP003. ;Secondary Objective: Other objectives are to evaluate the PSA doubling time in the treatment phase of Study SP010, and compare it with the PSA doubling time in Study SP003, to evaluate the PSA doubling time in the follow-up phase of Study SP010 and to determine the proportion of patients who had a progressive increase in PSA, objective disease progression or received further anticancer therapy within 2 years of enrolment; and to evaluate overall survival. An exploratory objective is to search for potential biomarkers that could play a role as prognostic factors, indicate the biological effect of ACI on immune-response or identify a subgroup of patients profiting from cancer immunotherapy based on gene expression profiling.;Primary end point(s): The primary endpoint of the study are safety measures such as incidence of Adverse Events, Serious Adverse Events, clinically significant laboratory abnormalities and changes in vital signs ;Timepoint(s) of evaluation of this end point: 2 years after enrollment | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): •PSA doubling time in the treatment phase, from Dose 1 to Dose 10 of the second immunotherapy cycle, i.e. in study SP010 •Comparing the PSA doubling time measured in the treatment phase of the second immunotherapy cycle, i.e. in Study SP010, with the PSA doubling time measured in the first immunotherapy cycle, i.e. in Study SP003 •PSA doubling time measured in the follow-up phase (from completed Visit 10 to 2 years from enrolment in the study •Comparing the PSA doubling time measured in the follow-up phase (from completed Visit 10 to 2 years from enrolment in the study) with the PSA doubling time in the treatment phase •The proportion of patients with objective clinical progression of the disease (evidence of metastases on bone scintigraphy or local progression or metastases on CT of the abdomen and small pelvis) within 2 years from the enrolment in the study •The proportion of patients who required any further anticancer therapy within 2 years from the enrolment in the study •The proportion of patients with progressive increase in PSA within 2 years from the enrolment in the study •Overall Survival Exploratory endpoints •Immune response •Gene expression profiling, and/or expression levels of a defined set of immune or cancer-related genes, respectively ;Timepoint(s) of evaluation of this end point: 2 years after enrollment | — |
Countries
Czech Republic
Contacts
Public ContactClinical Trials Sotio
SOTIO a.s.
Outcome results
None listed