TerminatedPhase 1

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

Stopped: Study was closed to accrual due to lack of drug supply.

United States18 participantsStarted 2017-02-08

Plain-language 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.

Who can participate

Age range18 Years

SexFEMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

* INCLUSION CRITERIA: * Patients must have histologically or cytologically confirmed advanced metastatic or unresectable epithelial ovarian cancer, primary peritoneal cancer or fallopian tube cancer that is relapsed and resistant (recurred less than 6 months after chemotherapy) or refractory (progressed on chemotherapy) to prior platinum- and taxane-based standard care systemic regimen. Or patients who are eligible for aditional platinum therapy. Histopathologic diagnosis must be confirmed in the Laboratory of Pathology (LP), National Cancer Institute (NCI). * Patients must have measurable or evaluable disease. Measurable disease is defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as greater than or equal to 20 mm with conventional techniques or as greater than or equal to 10 mm with spiral computed tomography (CT) scan. * Patients must be at least 4 weeks from previous therapy (chemotherapy, hormonal therapy, and radiation therapy, immunotherapy and monoclonal antibodies, alternative therapy or investigational therapeutic agents). There is no limitation on the amount of prior therapies allowed. Patients with ovarian cancer 4 weeks from previous therapy have been found to have normal monocyte function (unpublished). * Patients who have had cranial radiation therapy need to have completed it greater than or equal to 8 weeks prior to enrollment. * Pat…

What they're measuring

Overall Maximum Tolerated Dose of Intraperitoneal Autologous Monocytes

Timeframe: Cycle 1 Day 28

Overall Maximum Tolerated Dose of Sylatron (Peginterferon Alpha-2b)

Timeframe: Cycle 1 Day 28

Overall Maximum Tolerated Dose of Actimmune (Interferon Gamma-1b)

Timeframe: Cycle 1 Day 28

Trial details

NCT IDNCT02948426

SponsorNational Cancer Institute (NCI)

Sponsor typeNIH

Study typeINTERVENTIONAL

Primary completion2020-09-29

Results submitted2021-04-26

View on ClinicalTrials.gov More Fallopian Tube Cancer trials

Plain-language summary

Who can participate

Age range18 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.