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NCT02110069 · ClinicalTrials.gov registry record · Phase 2
A Study to Compare Vincristine to Sirolimus for Treatment of High Risk Vascular Tumors
A Phase 2 study, sponsored by Boston Children's Hospital.
- Terminated
- Registry status
- Phase 2
- Development phase
- 4
- Enrollment target
NCT02110069: Clinical Trial Phase 2 study, sponsored by Boston Children's Hospital.
NCT02110069 is a Phase 2 study that was terminated before completion, run by Boston Children's Hospital. The registered enrollment target is 4 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02110069, a Phase 2 study, was terminated before completion, sponsored by Boston Children's Hospital.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 4 participants
- Enrollment target
Study Summary
In this research study we want to learn more about which treatment works better for patients diagnosed with a vascular tumor called Kaposiform Hemangioendothelioma (KHE) or other high risk vascular tumors such as Tufted Angioma (TA). In these tumors, the blood cells that help your blood clot called platelets become trapped in the tumor causing swelling, pain, and bruising. Vascular tumors can be life threatening. There are few medical treatments that will work to shrink the vascular tumor. Some doctors will use steroids and vincristine to try and shrink vascular tumors. In this research study, the study doctor will compare two different drugs to see which one will work better to help shrink your vascular tumor. One of the drugs is vincristine. Vincristine is approved by the Food and Drug Administration (FDA) to treat people with cancer. Vincristine is used to stop the abnormal cells from growing such as cells that make up blood vessels. The other drug to be used in this study is sirolimus. Sirolimus is currently approved by the Food and Drug Administration (FDA) to prevent transplanted organ rejection. Sirolimus is not approved by the FDA for treatment of vascular abnormalities and is considered experimental. Sirolimus belongs to a class of drugs call 'mTOR inhibitors'. mTOR (mammilian target of rapamycin) helps cells to grow and may also help blood vessels to grow in a more normal fashion. Sirolimus is currently being tested in patients with vascular tumors and cancer. In vascular tumors, we hope sirolimus will stop the blood vessel growth. Funding Source: FDA - OOPD (Office of Orphan Products Development)
Primary Outcome
Hematologic parameters are defined as a platelet count greater than 100,000/uL (or a 2 times increase in platelet count compared to baseline) and a fibrinogen level greater than 150mg/dl.
Interventions
- DRUG Sirolimus
- DRUG Vincristine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 4 participants |
| Start Date | 2017-06-14 |
| Est. Completion | 2020-10-27 |
| Phase | Phase 2 |
Why NCT02110069 stopped before completion
NCT02110069 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 4 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 2 interventions - of which Sirolimus is the first listed.
NCT02110069 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02110069 about?
NCT02110069 is a clinical study titled "A Study to Compare Vincristine to Sirolimus for Treatment of High Risk Vascular Tumors". In this research study we want to learn more about which treatment works better for patients diagnosed with a vascular tumor called Kaposiform Hemangioendothelioma (KHE) or other high risk vascular tumors such as Tufted Angioma (TA). In these tumors, the blood cells that help your blood clot called ...
What is the current status of trial NCT02110069?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 4 participants. The study started on 2017-06-14. Estimated completion is 2020-10-27.
What interventions are being tested in trial NCT02110069?
The interventions under investigation include: Sirolimus (DRUG), Vincristine (DRUG).
Who is sponsoring clinical trial NCT02110069?
This trial is sponsored by Boston Children's Hospital, which has 462 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02110069's enrollment target sits among peer trials
4 2001st of 2000 the lowest of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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