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NCT05184816 · ClinicalTrials.gov registry record · Phase 1
A Study of Deferoxamine (DFO) in People With Leptomeningeal Metastasis
A Phase 1 study of Leptomeningeal Metastases, sponsored by Memorial Sloan Kettering Cancer Center.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 35
- Enrollment target
- 7
- Study locations
NCT05184816: Recruiting Phase 1 study of Leptomeningeal Metastases, sponsored by Memorial Sloan Kettering Cancer Center.
NCT05184816 is a Phase 1 study of Leptomeningeal Metastases that is actively recruiting participants, run by Memorial Sloan Kettering Cancer Center. The registered enrollment target is 35 participants, below the 54-participant average among 3 other Leptomeningeal Metastases trials with a reported enrollment target (35% lower). The trial reports 7 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05184816, a Phase 1 study of Leptomeningeal Metastases, is actively recruiting participants, sponsored by Memorial Sloan Kettering Cancer Center.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 35 participants
- Enrollment target
- 7
- Study locations
Study Summary
The researchers are doing this study to find out whether deferoxamine (DFO) given intrathecally (directly into the CSF) is a safe treatment for people with leptomeningeal metastasis from solid tumor cancer. The researchers will test different doses of DFO to find the highest dose that causes few or mild side effects. When the dose is found, they will test it in future participants to see whether DFO is a safe and effective treatment for people with leptomeningeal metastasis from solid tumor malignancies. They are also doing this study to see how the body absorbs, distributes, gets rid of, and responds to DFO.
Primary Outcome
Patients are considered evaluable for the primary safety endpoint of DLT if they receive at least one full cycle (twice weekly dosing for 4 weeks) without a DLT or if they experience a DLT at any time during the first cycle of IT-DFO. Per CTCAE version 5.0
Conditions Studied
Interventions
- DRUG Deferoxamine (DFO)
Study Locations (7)
New York
- Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities) - Commack
- Memorial Sloan Kettering Westchester (Limited Protocol Activities) - Harrison
- Memorial Sloan Kettering Cancer Center (All Protocol Activities) - New York
- Memorial Sloan Kettering Nassau (Limited Protocol Activities) - Uniondale
New Jersey
- Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities) - Basking Ridge
- Memorial Sloan Kettering Monmouth (Limited Protocol Activities) - Middletown
- Memorial Sloan Kettering Bergen (Limited Protocol Activities) - Montvale
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 35 participants |
| Start Date | 2021-12-22 |
| Est. Completion | 2026-12 |
| Phase | Phase 1 |
What NCT05184816 shows while recruiting
NCT05184816 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 35 participants, a relatively small participant target, below the 54-participant average among 3 other Leptomeningeal Metastases trials with a reported enrollment target (35% lower).
The record links to 1 condition, with Leptomeningeal Metastases appearing as the primary indexed condition, and to 1 intervention - of which Deferoxamine (DFO) is the first listed.
NCT05184816 lists 7 locations in 2 states (New York, New Jersey).
Frequently Asked Questions
What is clinical trial NCT05184816 about?
NCT05184816 is a clinical study titled "A Study of Deferoxamine (DFO) in People With Leptomeningeal Metastasis". The researchers are doing this study to find out whether deferoxamine (DFO) given intrathecally (directly into the CSF) is a safe treatment for people with leptomeningeal metastasis from solid tumor cancer. The researchers will test different doses of DFO to find the highest dose that causes few or ...
What is the current status of trial NCT05184816?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 35 participants. The study started on 2021-12-22. Estimated completion is 2026-12.
What conditions does trial NCT05184816 study?
This clinical trial studies the following conditions: Leptomeningeal Metastases.
What interventions are being tested in trial NCT05184816?
The interventions under investigation include: Deferoxamine (DFO) (DRUG).
Who is sponsoring clinical trial NCT05184816?
This trial is sponsored by Memorial Sloan Kettering Cancer Center, which has 1,884 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05184816 being conducted?
This trial has 7 study locations across New Jersey, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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