CENTAURO-4 Study

Phase 2

• Conditions: Cancer of ovary, fallopian tubes and / or peritoneum.; Carcinoma; Ovarian Neoplasms; Fallopian Tube Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Peritoneal Neoplasms; Abdominal Neoplasms; Ovarian Diseases; Genital Diseases, Female

• Registration Number: RPCEC00000246
• Lead Sponsor: Center for Genetic Engineering and Biotechnology (CIGB), in Havana.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-04-30
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Female
• Target Recruitment: 40

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 <5 times the upper limit for the normal value of the institution, if liver metastases are known.
- Alkaline phosphatase = 2.5 times the normal upper limit.
- Creatinine: Within normal limits for each institution or creatinine clearance> 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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.