Clinical trial in patients with localized prostate cancer after primary radical prostatectomy treated with second cycle of active cellular immunotherapy with DCVAC/PCa and without objective progression on the first cycle of DCVAC/PCa

Phase 1

Active, not recruiting

• Conditions: ocalized prostate cancer; MedDRA version: 19.0Level: PTClassification code 10060862Term: Prostate cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2013-003809-26-CZ
• Lead Sponsor: SOTIO a.s.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-10-04
• Last Update Posted: 22 May 2017

Recruitment & Eligibility

• Status: Not Recruiting
• Sex: Male
• Target Recruitment: Not specified

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

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified