Cancer of ovary, fallopian tubes and / or peritoneum.
Conditions
Interventions
Group I (experimental): Chemotherapy (Carboplatin and paclitaxel, 6 cycles every 21 days) b y intravenous route + Antigen p64K-hVEGFKDR- (800 µg) + synthetic NAcGM3s/VSSP (200 µg) applied subcutaneous
Carboplatin
Paclitaxel
Vaccines
Administration, Intravenous
Injections, Subcutaneous
CIGB-247,
NAcGM3s/VSSP,
Aluminum Phosphate,
p64K-hVEGFKDR Antigens
Sponsors
Center for Genetic Engineering and Biotechnology (CIGB), in Havana.
Eligibility
Sex/Gender
Female
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1) Patients with confirmed cytological / histological criteria for ovarian epithelial carcinoma, fallopian tubes and / or peritoneum. 2) Age between 18 and 75 years, both inclusive. 3) Patients with Performance status 0-1 4) Patients with normal hepatic, renal and hematologic functions defined by: - Hemoglobin = 90 g / L (patients with lower levels of Hb can be transfused and reevaluate inclusion) - Total Leukocyte Count = 3.0 x 109 / L - Absolute Neutrophil Count = 1.5 x 109 / L - Platelet count = 100 x 109 / L - Bilirubin up to the normal upper limit. - TGP and TGO: up to = 1.5 times the upper limit for the normal value of the institution, or 50 mL / min / 1.73 m2 for patients with creatinine levels above the normal value of the institution For patients with bone metastases, the inclusion of patients with alkaline phosphatase <5 x ULN will be permitted, provided that ALT and AST <1.5 x ULN, assuming in these cases that the elevation of alkaline phosphatase is due exclusively to metastases Bony 5) Voluntary patient by signing the informed consent.
Exclusion criteria
Exclusion criteria: 1) Patients included in another clinical trial and who have received any biological therapy under investigation, including active or passive immunotherapy in the last 6 months. 2) Referred immunosuppressive disease; Ingestion of immunosuppressive / immunomodulatory drugs. 3) Patient with tumor or brain metastasis. 4) Decompensated chronic diseases (hypertension, diabetes mellitus, chronic renal failure, heart failure, hyperthyroidism, epilepsy). 5) Moderate or severe systemic infections that interfere with patient assessment. 6) History of allergy to any ingredient in the vaccine under study. 7) Patients who are pregnant or breastfeeding: (Patients of childbearing age should have a negative pregnancy test before starting treatment and follow a contraceptive method approved during the study and up to 3 months later) 8) Obvious mental incapacity to issue consent and act accordingly with the study. 9) Patients with no feasibility of attending scheduled follow-up.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival (Time from inclusion in the study to the onset of progressive disease or death). Measurement time: months 1, 6, 12, 18 and 24 after the start of treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Global Survival (Time from randomization of the patient in the study to the death or date of latest news). Measurement time: months 1, 6, 12, 18 and 24 after the start of treatment 2. Objective response: To be evaluated according to the criteria of RECIST (Response evaluation criteria in solid tumors). Patients will be classified as: complete response, partial response, stable disease or progressive disease. Measurement time: every 3 months until 24 months. 3. Humoral immune response (determination of anti-VEGF antibody titres; percent inhibition - VEGF binding and its receptor) and cellular (ELISPOT for interferon gamma: average number of spots). Time of measurement: at weeks 13, 25, 49 and 73 (humoral response); At week 49 (cell response). 4. Quality of life (through validated EORTC survey for this disease QLQ-C30 and QLQ-LC13). Measurement time: every 3 months until 24 months. 5. Adverse clinical events (occurrence of AD (Yes, No) Description of AD (event name) Intensity of AD (mild, moderate, severe) Measurement time: at baseline, weekly in during the first 8 immunizations, and thereafter with a monthly frequency until 24 months. 6. Laboratory (numerical values ??of hematological and biochemical tests). Measurement time: initial and in Measurement time: at weeks 13, 25, 49 and 73. | — |
Countries
Cuba
Contacts
Public ContactIdania Baladron Castrillo
Center for Genetic Engineering and Biotechnology (CIGB).
Outcome results
None listed