Last updated on January 2020

Intraperitoneal Infusion of Autologous Monocytes With Sylatron (Peginterferon Alfa-2b) and Actimmune (Interferon Gamma-1b) in Women With Recurrent or Refractory Ovarian Cancer Fallopian Tube Cancer or Primary Peritoneal Cancer


Brief description of study

Ovarian cancer is a leading cause of cancer death in women. Monocytes are white blood cells that slow tumor growth. Interferons (IFNs) are molecules that help immune cells fight cancer. Researchers want to stimulate monocytes with IFNs. They want to test if these stimulated monocytes combined with the drugs Sylatron and Actimmune can shrink tumors and slow the progression of cancer.

Objective

To test how well IFN stimulated monocytes, with Sylatron and Actimmune, kill tumor cells.

Eligibility

Women ages 18 and older with certain ovarian, fallopian tube, or peritoneal cancers

Design

Participants will be screened with:

Medical history

Physical exam

Blood and urine tests

Scan

Results or sample from previous biopsy

Participants may have a tumor sample taken.

Participants who do not have a port will have a catheter placed inside the abdominal cavity. It will be used to give the treatment.

Participants will have visits for 4 days of each 28-day cycle. This includes overnight observation.

Participants with ascites fluid in their abdominal cavity will have it sampled twice.

Each cycle, participants will have:

Blood tests

Leukapheresis. Some blood is removed and put through a machine that separates out the monocytes. The rest of the blood is returned to the body.

Infusion of the monocytes and study drugs

Participants will have weekly phone calls in Cycle 1 and scans every 2 cycles.

Participants will continue treatment until they can no longer tolerate it or their cancer gets worse.

Participants will have a visit about 1 month after stopping treatment, then monthly phone calls.

Detailed Study Description

Background
  • Monocytes can differentiate into classic M1 macrophages inhibiting tumor proliferation and promoting natural killer (NK) cell differentiation.
  • Human alpha interferons (interferon alfa, IFN-alpha), interferon gamma (IFN-gamma) and monocytes have strong anti-neoplastic response in vitro and in vivo
  • IFN-alpha and IFN-gamma have been shown in early phase clinical trials to be safely administered intraperitoneally.
  • Intraperitoneal monocytes alone or activated with IFN-gamma are safe and feasible as demonstrated in phase I clinical studies.
  • We have shown that the combination of human monocytes, IFN-alpha2a and IFN-gamma1b, or pegylated IFN-alpha, act synergistically against tumor cells in vitro and in mouse models.
    Objectives

-To identify a maximum tolerated dose of intraperitoneal autologous monocytes and Sylatron(R) (Peginterferon alfa-2b) and Actimmune(R) (Interferon gamma-1b).

Eligibility
  • Advanced metastatic or unresectable epithelial ovarian cancer, primary peritoneal cancer or fallopian tube cancer that is relapsed and resistant or refractory to prior platinum-based standard care systemic regimen.
  • Patients must be off prior chemotherapy, radiation therapy, hormonal therapy or biological therapy for at least 4 weeks.
  • ECOG performance status 0-1 and adequate organ and marrow function.
Design
  • This is an open label single arm phase I trial to determine the maximum tolerated dose of intraperitoneal monocytes and Sylatron(R) (Peginterferon alfa-2b) and Actimmune(R) (Interferon gamma-1b).
  • Autologous monocytes obtained through apheresis will be mixed with Sylatron(R) (Peginterferon alfa-2b) and Actimmune(R) (Interferon gamma-1b) in a 3 + 3 dose escalation and administered intraperitoneally once every 28 days. A new product will be manufactured for each treatment cycle.
  • Once the maximum tolerated dose is obtained, an expansion cohort will be enrolled to better quantify response rate and time to disease progression.
  • Research samples including peripheral blood and ascites will be obtained prior to the initiation of study therapy andprior to the start of each cycle. Tissue biopsies will be obtained in the dose expansion phase to characterize the immune infiltration.
  • Patients will be evaluated every 2 cycles for response using RECIST v1.1 and every cycle for safety using CTCAE v4.0.

Clinical Study Identifier: NCT02948426

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