Bleomycin sulfate for Recurrent vulvar carcinoma

Inclusion criteria

• {"criterion_text":"-\tAge ≥ 18 years old"}
• {"criterion_text":"-\tRecurrent VC confirmed by histological examination"}
• {"criterion_text":"-\tPatient who underwent multiple treatments (surgery and radiation therapy or chemoradiation, radiation therapy or chemoradiation and chemotherapy)."}
• {"criterion_text":"-\tPatient 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 )"}
• {"criterion_text":"-\tLife expectancy more than three months"}
• {"criterion_text":"-\tMeasurable disease according to RECIST 1.1"}
• {"criterion_text":"-\tAdequate bone marrow, liver, and kidney function (creatinine <1.5 mg/dl), and coagulation parameters as follows: o\tBone marrow (Hemoglobin ≥ 8.0 g/dL with or without transfusion support, Platelet count ≥ 75 × 109/L?) o\tINR >1.5; o\tAspartate aminotransferase (AST)/serum glutamic-oxaloacetic transaminase (SGOT), alanine aminotransferase (ALT)/serum glutamic-pyruvate transaminase (SGPT) ≤3.0 × upper limit of normal (ULN) o\tTotal bilirubin ≤2.0 × ULN or ≤3 × ULN except for subjects with Gilbert’s syndrome o\tSerum creatinine <1.5 mg/dl and creatinine clearance > 30 ml/min All blood assessments must be performed within 15 days from ECT treatment."}
• {"criterion_text":"-\tFor females of childbearing potential, a negative serum pregnancy human chorionic gonadotropin (hCG) pregnancy test within 72 hours of study Day 1."}
• {"criterion_text":"-\tSigned 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

• {"criterion_text":"-\tHistory of other malignancies in the previous five years, except basal cell carcinoma of the skin."}
• {"criterion_text":"-\tHistory of psychological, familial, sociological, or geographical condition potentially preventing compliance with the study protocol and follow-up schedule."}
• {"criterion_text":"-\tAllergic reactions to the two chemotherapy drugs (BLM and AUC2-CARBOPLATIN) and/or their excipients."}
• {"criterion_text":"-\tEvidence of pulmonary fibrosis."}
• {"criterion_text":"-\tHistory of clinically significant cardiovascular abnormalities such as congestive heart failure (New York Heart Association classification ≥ II [NYHA 1994]), myocardial infarction within 6 months of study entry."}
• {"criterion_text":"-\tPatients requiring treatment for systemic bacterial, fungal, or viral infection ongoing at the day of the procedure. (Patients on antimicrobial, antifungal, or antiviral prophylaxis are not excluded)."}
• {"criterion_text":"-\tPregnant or breastfeeding."}
• {"criterion_text":"-\tDisability to understand and complete the questionnaire due to language difficulties, severe psychiatric illness or dementia. Unstable or severe uncontrolled medical condition (e.g., unstable cardiac function, unstable pulmonary condition, uncontrolled diabetes) or any important medical illness or abnormal laboratory finding that would, in the Investigator’s judgment, increase the risk to the patient associated with his or her participation in the study"}

Primary endpoints

• {"endpoint_text":"-\tlocal progression free survival","definition_or_measurement_approach":""}

Italy

Earliest CTIS Part Ii Submission Date

23-09-2024

Latest Decision Or Authorization Date

27-11-2024

Processing Time Days

65

Number Of Sites

1

Number Of Participants

92

Primary sponsor

Full Name

Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Italy