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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

NCT02948426 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2026-01-08

Study results available
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Summary

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.

Conditions

Interventions

BIOLOGICAL

Autologous Monocytes + ACTIMMUNE + SYLATRON

The autologous monocytes cell product in 250ml total volume of investigational combination (monocytes + ACTIMMUNE + SYLATRON) is infused via the intraperitoneal catheter over 30-60 min +/- 10 min every 28 days +/- 7 days until disease progression, limiting toxicity, intercurrent medical issues, or patient withdrawal. Dosing is based on a dose escalation design including an expansion cohort at the maximum tolerated dose (MTD).

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    lead NIH

Principal Investigators

  • Stanley Lipkowitz, M.D. · National Cancer Institute (NCI)

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-02-08
Primary Completion
2020-09-29
Completion
2020-09-29
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02948426 on ClinicalTrials.gov