Intraperitoneal Infusion of Autologous Monocytes With Sylatron (Peginterferon Alfa-2b) and Actimm… (NCT02948426) | Clinical Trial Compass
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 range
18 Years
Sex
FEMALE
See this in plain English?
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Overall Maximum Tolerated Dose of Intraperitoneal Autologous Monocytes
Timeframe: Cycle 1 Day 28
2
Overall Maximum Tolerated Dose of Sylatron (Peginterferon Alpha-2b)
Timeframe: Cycle 1 Day 28
3
Overall Maximum Tolerated Dose of Actimmune (Interferon Gamma-1b)