A Study of Deferoxamine (DFO) in People With Leptomeningeal Metastasis
ConditionLeptomeningeal Metastases
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorMemorial Sloan Kettering Cancer Center
About this trial
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.
Eligibility criteria
Qualifiers
Age ≥ 18 years on the day of consenting to study
ECOG performance status ≤ 2 or KPS ≥ 60.
Life expectancy ≥ 8 weeks in the opinion of the Investigator
Newly diagnosed: As evidenced by positive CSF cytology, CTC count >3.0/3.0 mL, or unequivocal radiographic evidence of LM on contrast-enhanced MRI, OR
Disqualifiers
Any CNS-directed irradiation within 7 days of first dose of IT-DFO.
Patients receiving other therapy (either intrathecal or systemic) designed to treat their LM, with ongoing acceptable control of their LM.
Any contraindication to gadolinium-enhanced MRI
Use of any systemic iron chelators within 4 weeks of first dose
Trial design
Treatments tested in this trial
- Deferoxamine (DFO)
Treatment groups
35 Participants
are divided into 1 treatment groupSponsors and collaborators
Memorial Sloan Kettering Cancer Center
Lead sponsor
Center for Experimental Therapeutics
Collaborator
F.M. KIRBY FOUNDATION
Collaborator
Source ClinicalTrials.gov