MC1963 Folate Receptor Alpha Dendritic Cells (FRαDCs) or Placebo for Patients With Advanced Stage Ovarian Cancer: A Phase II Double-Blind Randomized Clinical Trial (FAROUT)

Summary

This phase II trial compares the effect of folate receptor alpha dendritic cells (FRαDCs) to placebo in treating patients with stage III or IV ovarian, fallopian tube or primary peritoneal cancer. FRαDCs, 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. FRαDCs 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 FRαDCs 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.

Description

Eligibility

Age range

18+ years

Sex

Female

Healthy volunteers

No

Interventions

• Procedure
  Biopsy

  Undergo biopsy

• Procedure
  Biospecimen Collection

  Undergo blood sample collection

• Procedure
  Computed Tomography

  Undergo CT

• Biological
  Diphtheria Toxoid/Tetanus Toxoid/Acellular Pertussis Vaccine Adsorbed

  Given IM

• Procedure
  Leukapheresis

  Undergo leukapheresis

• Procedure
  Magnetic Resonance Imaging

  Undergo MRI

• Biological
  Multi-epitope Folate Receptor Alpha-loaded Dendritic Cell Vaccine

Locations (3)