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NCT02948426 · ClinicalTrials.gov registry record · Phase 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
A Phase 1 study, sponsored by National Cancer Institute (NCI).
- Terminated
- Registry status
- Phase 1
- Development phase
- 18
- Enrollment target
NCT02948426: Clinical Trial Phase 1 study, sponsored by National Cancer Institute (NCI).
NCT02948426 is a Phase 1 study that was terminated before completion, run by National Cancer Institute (NCI). The registered enrollment target is 18 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02948426, a Phase 1 study, was terminated before completion, sponsored by National Cancer Institute (NCI).
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 18 participants
- Enrollment target
Study 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.
Interventions
- BIOLOGICAL Autologous Monocytes + ACTIMMUNE + SYLATRON
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2017-02-08 |
| Est. Completion | 2020-09-29 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02948426
The ClinicalTrials.gov registry entry for NCT02948426 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 18 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Autologous Monocytes + ACTIMMUNE + SYLATRON is the first listed.
NCT02948426 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02948426 about?
NCT02948426 is a clinical study titled "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". 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 t...
What is the current status of trial NCT02948426?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 18 participants. The study started on 2017-02-08. Estimated completion is 2020-09-29.
What interventions are being tested in trial NCT02948426?
The interventions under investigation include: Autologous Monocytes + ACTIMMUNE + SYLATRON (BIOLOGICAL).
Who is sponsoring clinical trial NCT02948426?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
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