Alpha particle radiopharmaceuticals from bench to bedside

The multidisciplinary competence in the Targeted Alpha Therapy (TAT) group and associated clinicians at the Sahlgrenska University Hospital, (Oncology, Radiation therapy, Gynecology (surgical /oncology), Radiation physics, Radiopharmaceutical chemistry, Nuclear physics (Cyclotron production 211-astatine, at Rigshospitalet, Copenhagen) and Statistics) has proven successful.

Resulting in the first ever phase I alpha particle radioimmunotherapy (RIT) with i.p. treatment in ovarian cancer.This project builds on already performed preclinical to phase-I studies in ovarian cancer, proving our capacity to perform this complex clinical research.

The proposed phase IIA study will (if positive) prove a proof-of-principle, that alpha particle RIT can eradicate, clinically undetected, i.p. microscopic disease and increase cure for women with ovarian cancer.Within five-year we propose to perform:phase I safety-pharmacokinetics including detailed dosimetryphase IIA clinical effect in an open-labeled parallel randomized study.QoL and Health Economics run in parallelPopulation: Females with stage IIb-III epithelial ovarian cancer, aged 40-80-years in clinical (CA-125 and CT-verified) remission, after standard cytoreductive surgery and standard platinum/taxane based chemotherapy.

Intervention: I.p radioimmunotherapy boost of 211At-farletuzumab (anti-Folate receptor alpha).Control: Randomization (1:1) between treatment or no treatment.Outcome: Primary end-point: peritoneal recurrence-free time