Electrochemotherapy With Carboplatinum Plus Bleomycin Versus Bleomycin Alone in Vulvar Cancer

Launched by IRCCS AZIENDA OSPEDALIERO-UNIVERSITARIA DI BOLOGNA · May 25, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment approach for women with vulvar cancer that has come back after previous treatments like surgery or radiation. The trial compares two groups: one group will receive a combination of two drugs, Bleomycin and Carboplatin, delivered with a technique called electrochemotherapy, while the other group will receive only Bleomycin. The main goals are to see which treatment helps control the cancer better, improve patients' quality of life, and find out more about any side effects or complications from the treatments.

To join the study, participants must be at least 18 years old and have a confirmed diagnosis of recurrent vulvar cancer. They should have already undergone multiple treatments and may not be eligible for standard therapies due to their health status. Participants can expect to fill out questionnaires about their quality of life and will be closely monitored throughout the trial. This study is currently recruiting participants, and all potential candidates will need to provide informed consent to ensure they understand what’s involved in the trial.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • Age ≥ 18 years old
• • Recurrent VC confirmed by histological examination
• • Patient who underwent multiple treatments (surgery and radiation therapy or chemoradiation, radiation therapy or chemoradiation and chemotherapy).
• • Patient not eligible for standard therapies (surgery, radiation therapy and systemic chemotherapy in case of metastatic disease) due to the performance status (ECOG Performance Status ≥ 3 )
• • Life expectancy more than three months
• • Measurable disease according to RECIST 1.1
• * Adequate bone marrow, liver, and kidney function (creatinine \<1.5 mg/dl), and coagulation parameters as follows:
• • Bone marrow (Hemoglobin ≥ 8.0 g/dL with or without transfusion support, Platelet count ≥ 75 × 109/L?) o INR \>1.5;
• • Aspartate aminotransferase (AST)/serum glutamic-oxaloacetic transaminase (SGOT), alanine aminotransferase (ALT)/serum glutamic-pyruvate transaminase (SGPT) ≤3.0 × upper limit of normal (ULN)
• • Total bilirubin ≤2.0 × ULN or ≤3 × ULN except for subjects with Gilbert's syndrome
• • Serum creatinine \<1.5 mg/dl and creatinine clearance \> 30 ml/min All blood assessments must be performed within 15 days from ECT treatment.
• • For females of childbearing potential, a negative serum pregnancy human chorionic gonadotropin (hCG) pregnancy test within 72 hours of study Day 1.
• • Signed informed consent obtained prior to initiation of any study-specific procedures and treatment as confirmation of the patient's awareness and willingness to comply the study requirements.
• Exclusion Criteria:
• • History of other malignancies in the previous five years, except basal cell carcinoma of the skin.
• • History of psychological, familial, sociological, or geographical condition potentially preventing compliance with the study protocol and follow-up schedule.
• • Allergic reactions to the two chemotherapy drugs (BLM and AUC2-CARBOPLATIN) and/or their excipients.
• • Evidence of pulmonary fibrosis.