Stage III of high malignancy Ovarian serous adenocarcinoma MedDRA version: 21.1 Level: PT Classification code 10070907 Term: Ovarian cancer stage III System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Product Name: Dendritic Cells Preparation
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: Dendritic Cells Vaccine for ovarian cancer
Other descriptive name: CELL SUSPENSION CONTAINI
Sponsors
UAB Froceth
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Has a major, stage III, high malignancy (G2-G3) ovarian adenocarcinoma confirmed by histological examination and no BRCA1/2 gene mutation has been identified; • Optimal citoreduction was performed (R0); • Post-operative chemotherapy with combination of carboplatin and paclitaxel is indicated; • Signed Informed consent form; • Age 18-70 • Karnovsky Index> 70%, ECOG 0-1; • Hemoglobin concentration = 110 g / l; • Leukocyte count = 3 × 109 / l, neutrophil count = 1.5 × 109 / l, lymphocyte count = 0.5 × 109 / l, platelet count = 100 × 109 / l, monocyte count = 0.2 × 109 / l; • Albumin concentration> 25 g / l; • CRP - not more than 20 mg / L (and without signs of infection), creatinine - up to 140 mkmol / L, • Normal or no more than 5 times the upper limit of normal for the following biochemical tests: AST, ALT, bilirubin (total, direct), pancreatic a-amylase; • Prothrombin time (TNS / INR = 0.7-2.5); • Negative blood test results for HIV-1/2, HBV (anti-HBcor + anti-HBs + HBsAg), HCV and syphilis (RPR and TPHA) infections; • Do not suffer from autoimmune diseases, active tuberculosis, acute or chronic boreal (Lyme disease); • Do not suffer from severe cardiovascular disease (acute or chronic arrhythmia, unstable angina pectoris, uncontrolled heart failure (NYHA class IV), cerebral ischemic stroke or myocardial infarction in the last 12 months) 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 34 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10
Exclusion criteria
Exclusion criteria: • BRCA1 / 2 gene mutation has been identified; • Suffer from unstable or / and complicated respiratory, digestive, urogenital, endocrine, metabolic and haematological diseases that may affect the patient's survival (eg unstable angina, severe chronic obstructive pulmonary disease, etc.) ; • Have autoimmune diseases (rheumatoid arthritis, systemic lupus erythematosus, type I diabetes, heavy myasthenia, dermatomyositis, etc.); • Have had other localized malignancies in the last ten years, except for epithelial skin tumors (basal cell carcinoma and non-widespread flat cell carcinoma); • Severe post-operative complications (sepsis, peritonitis due to bowel anostomosis, intra-abdominal abscesses, etc.) which, according to the investigator, is significant related to the immune system response
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the safety and tolerability of autologous dendritic cell preparations (DCPs) in combination with carboplatin and paclitaxel in patients with stage III high malignancy G2-G3 ovarian serous adenocarcinoma.;Secondary Objective: 1. To evaluate the effect of immunotherapy with DCP in combination with carboplatin and paclitaxel on the survival of patients with stage III high malignancy ovarian serous adenocarcinoma until the first progression of the disease. 2. To evaluate the effect of immunotherapy with DCP in combination with carboplatin and paclitaxel on the overall survival of patients with stage III high malignancy ovarian serous adenocarcinoma. 3. To evaluate the changes in quality of life according to EORTC (QLQ C30 (3rd edition) and QLQ OV28) criteria using DCP. 4. To identify immunological markers whose values or dynamics would be associated with a positive response to DCP treatment. ;Primary end point(s): Adverse events in treatment group; safety difference between the study groups;Timepoint(s) of evaluation of this end point: THE SAFETY OF TREATMENT WILL BE ASSESSED: • according to the CTCAE v5.0 (Common Terminology Criteria for Adverse Events) description; • according to the ECG: before the first course of chemotherapy; 5-10 days after the third course of chemotherapy; 28 d. after VI chemotherapy injection; 84 days after completion of chemotherapy • according to general blood and biochemical tests (general blood and biochemical tests are performed in a local laboratory according to the methodologies used in clinical practice): - before each course of chemotherapy; - after 4, 8, and 12 weeks. after chemotherapy (study group) and 4, 12 weeks. after chemotherapy (control group); -in follow up until disease progression as clinically indicated. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Differences in overall survival between the study groups 2. The time of onset of disease progression in patients in the treatment group 3. Changes of immunological markers in the treatment group compared to baseline. 4. Changes of quality of life compared to between the study groups ;Timepoint(s) of evaluation of this end point: 1. The computer tomography and marker Ca-125 will be tested: • before postoperative treatment • every 2 months until 12 months after the chemotherapy end, then every 3 months until the first progression of the disease; 2. The immunoprofile: • before the start of post-operative treatment; • 5-10 days after the 3rd chemotherapy course; • 4 weeks after chemotherapy (control group) or chemoimmunotherapy (study group) 3. Changes in quality of life will be recorded: - during randomization; - before each course of chemotherapy; - after 4 and 8 weeks after chemotherapy, later every 3 months until the first progression of the disease (study group); - every 3 months after completion of chemotherapy until the first progression of the disease (control group) | — |
Countries
Lithuania
Contacts
Public ContactClinical Trials Information
UAB Froceth
Outcome results
None listed