Folate Receptor Alpha Dendritic Cells (FRDCs) or Placebo for the Treatment of Patients With Stage III or IV Ovarian, Fallopian Tube, or Primary Peritoneal Cancer, FAROUT Trial

• Status: RECRUITING
• Trial end date: 2027-12-31

Summary

This phase II trial compares the effect of folate receptor alpha dendritic cells (FRDCs) to placebo in treating patients with stage III or IV ovarian, fallopian tube or primary peritoneal cancer. FRDCs, a dendritic cell vaccine, is made from a person's white blood cells. The white blood cells are treated in the laboratory to make dendritic cells (a type of immune cell) mixed with folate receptor alpha (FRalpha), a protein found in high levels on ovarian tumor cells. FRDCs work by boosting the immune system to recognize and destroy the tumor cells by targeting the FRalpha protein on the tumor cell. Placebo is an inactive substance that looks the same as, and is given the same way as, the active drug or treatment being tested. The effects of the active drug are compared to the effects of the placebo. Giving FRDCs may work better in preventing or delaying recurrence compared to placebo in patients with stage III or IV ovarian, fallopian tube, or primary peritoneal cancer.

• Phase: PHASE2

Details

• Lead Sponsor: Mayo Clinic
• Treatments: adacel; Biopsy; Diphtheria Toxoid; Diphtheria-Tetanus Vaccine; Diphtheria-Tetanus-acellular Pertussis Vaccines; Leukapheresis; Magnetic Resonance Spectroscopy; Specimen Handling; Tetanus Toxoid