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NCT03120624 · ClinicalTrials.gov registry record · Phase 1
VSV-hIFNbeta-NIS With or Without Ruxolitinib Phosphate in Treating Stage IV or Recurrent Endometrial Cancer
A Phase 1 study of Recurrent Endometrial Carcinoma and Recurrent Endometrial Endometrioid Adenocarcinoma, sponsored by Mayo Clinic.
- Active
- Registry status
- Phase 1
- Development phase
- 34
- Enrollment target
- 1
- Study location
NCT03120624: Active Phase 1 study of Recurrent Endometrial Carcinoma and Recurrent Endometrial Endometrioid Adenocarcinoma, sponsored by Mayo Clinic.
NCT03120624 is a Phase 1 study of Recurrent Endometrial Carcinoma and Recurrent Endometrial Endometrioid Adenocarcinoma that is active but no longer recruiting, run by Mayo Clinic. The registered enrollment target is 34 participants, below the 251-participant average among 19 other Recurrent Endometrial Carcinoma trials with a reported enrollment target (86% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03120624, a Phase 1 study of Recurrent Endometrial Carcinoma and Recurrent Endometrial Endometrioid Adenocarcinoma, is active but no longer recruiting, sponsored by Mayo Clinic.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 34 participants
- Enrollment target
- 1
- Study location
Study Summary
This phase I trial studies the side effects and best dose of vesicular stomatitis virus-human interferon beta-sodium iodide symporter (VSV-hIFNbeta-NIS) with or without ruxolitinib phosphate in treating patients with stage IV endometrial cancer or endometrial cancer that has come back. The study virus, VSV-hIFNbeta-NIS, has been changed so that it has restricted ability to spread to tumor cells and not to healthy cells. It also contains a gene for a protein, NIS, which helps the body concentrate iodine making it possible to track where the virus goes. VSV-hIFNbeta-NIS may be able to kill tumor cells without damaging normal cells. Ruxolitinib phosphate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving VSV-hIFNbeta-NIS with ruxolitinib phosphate may work better in treating patients with endometrial cancer compared to VSV-hIFNbeta-NIS alone.
Primary Outcome
Graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4. DLT is defined as one of the following events deemed related to the study drug; Grade 2+ allergic reaction or cytokine release syndrome, or any grade 3+ with the exception of lymphopenia or other related events (e.g., anemia, white blood cell count decreased), which will not be considered a dose limiting toxicity. Grade ≥3 flu-like symptoms, fever, nausea, vomiting, dehydrati
Conditions Studied
Interventions
- PROCEDURE Computed Tomography
- PROCEDURE Biopsy
- PROCEDURE Positron Emission Tomography
- OTHER Pharmacological Study
- OTHER Fluorine F 18 Tetrafluoroborate
Study Locations (1)
Minnesota
- Mayo Clinic in Rochester - Rochester
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 34 participants |
| Start Date | 2017-09-15 |
| Est. Completion | 2028-01-01 |
| Phase | Phase 1 |
What the registry record for NCT03120624 still lists
NCT03120624 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 34 participants, a relatively small participant target, below the 251-participant average among 19 other Recurrent Endometrial Carcinoma trials with a reported enrollment target (86% lower).
The record links to 10 conditions, with Recurrent Endometrial Carcinoma appearing as the primary indexed condition, and to 5 interventions - of which Computed Tomography is the first listed.
NCT03120624 reports a single indexed study location in Minnesota.
Frequently Asked Questions
What is clinical trial NCT03120624 about?
NCT03120624 is a clinical study titled "VSV-hIFNbeta-NIS With or Without Ruxolitinib Phosphate in Treating Stage IV or Recurrent Endometrial Cancer". This phase I trial studies the side effects and best dose of vesicular stomatitis virus-human interferon beta-sodium iodide symporter (VSV-hIFNbeta-NIS) with or without ruxolitinib phosphate in treating patients with stage IV endometrial cancer or endometrial cancer that has come back. The study vir...
What is the current status of trial NCT03120624?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 34 participants. The study started on 2017-09-15. Estimated completion is 2028-01-01.
What conditions does trial NCT03120624 study?
This clinical trial studies the following conditions: Recurrent Endometrial Carcinoma, Recurrent Endometrial Endometrioid Adenocarcinoma, Metastatic Endometrial Carcinoma, Recurrent Endometrial Serous Adenocarcinoma, Recurrent Endometrial Clear Cell Adenocarcinoma.
What interventions are being tested in trial NCT03120624?
The interventions under investigation include: Computed Tomography (PROCEDURE), Biopsy (PROCEDURE), Positron Emission Tomography (PROCEDURE), Pharmacological Study (OTHER), Fluorine F 18 Tetrafluoroborate (OTHER).
Who is sponsoring clinical trial NCT03120624?
This trial is sponsored by Mayo Clinic, which has 2,844 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03120624 being conducted?
This trial has 1 study location across Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03120624's enrollment target sits among peer trials
34 12th of 19 higher than 8 of 19 other Recurrent Endometrial Carcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Recurrent Endometrial Carcinoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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