Clinical Trial: Vaccine Therapy in Treating Patients With Stage IIIC-IV Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cavity Cancer Following Surgery and Chemotherapy

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: A Pilot Study of the Safety and Immunogenicity of Folate Receptor Alpha Peptide-Loaded Dendritic Cell Vaccination in Patients With Advanced Stage Epithelial Ovarian Cancer

Brief Summary: This pilot clinical trial studies the safety and immunogenicity of vaccine therapy in treating patients with stage IIIC-IV ovarian epithelial, fallopian tube, or primary peritoneal cavity cancer following surgery and chemotherapy. Vaccines made from a person's peptide treated white blood cells may help the body build an effective immune response to kill tumor cells.

Detailed Summary:

PRIMARY OBJECTIVES:

I. Determine the safety and tolerability of folate receptor alpha dendritic cell (FRalphaDC) vaccination (folate receptor alpha-peptide loaded dendritic cell vaccine).

SECONDARY OBJECTIVES:

I. Measure time to disease recurrence of patients treated with FRalphaDCs. II. Measure overall survival of patients treated with FRalphaDCs.

TERTIARY OBJECTIVES:

I. Determine whether FRalphaDC vaccination induces an increase in the number of FRalpha-specific interleukin (IL)-17-secreting T helper (Th) cells, as determined by enzyme-linked immunosorbent spot (ELISpot).

II. Determine whether FRalphaDC vaccination induces an increase in the number of FRalpha-specific T cells that secrete interferon (IFN)gamma, tumor necrosis factor (TNF)alpha, IL-10, and granzyme B, as determined by ELISpot.

III. Determine whether FRalphaDC vaccination induces antibodies specific for FRalpha.

IV. Determine whether FRalphaDC vaccination induces a delayed type hypersensitivity (DTH) skin reaction specific for FRalpha.

V. Measure FRalpha expression in patients' primary tumors and in tumors that recur after FRalphaDC vaccine treatment (when available).

VI. Determine whether FRalphaDC vaccination is associated with changes in peripheral blood immune cell subsets.

OUTLINE: This is a dose-escalation study.

INDUCTION PHASE: Patients receive folate recept
Sponsor: Mayo Clinic

Current Primary Outcome: Incidence of dose-limiting toxicities (DLT), graded using the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 [ Time Frame: Up to 3 weeks ]

If the accrual schema is completed and there are fewer than 5 patients with a DLT, the vaccination treatment will be considered safe in this patient population.


Original Primary Outcome: Incidence of dose-limiting toxicities (DLT), graded using the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 [ Time Frame: Up to 3 weeks ]

If the accrual schema is completed and there are fewer than 4 patients with a DLT, the vaccination treatment will be considered safe in this patient population


Current Secondary Outcome:

  • Overall survival (OS) [ Time Frame: Number of days from study registration until death due to any cause, assessed up to 5 years ]
    The Kaplan-Meier method will be used to estimate the distribution of OS.
  • Time to disease recurrence (TDR) [ Time Frame: Number of days from study registration until disease recurrence or death, assessed up to 5 years ]
    The Kaplan-Meier method will be used to estimate the distribution of TDR.


Original Secondary Outcome:

Information By: Mayo Clinic

Dates:
Date Received: April 7, 2014
Date Started: April 2014
Date Completion:
Last Updated: December 28, 2016
Last Verified: November 2016