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A Study of Deferoxamine (DFO) for Leptomeningeal Metastasis

This study is testing a drug called Deferoxamine (DFO) given directly into the fluid around your brain and spinal cord (intrathecally) for people with leptomeningeal metastasis (LM) from solid tumor cancers. Researchers want to find the safest and most effective dose of DFO. They will start with small doses and gradually increase them to see what side effects occur. The study will also look at how your body handles DFO. You may be able to join if you are at least 18 years old, have LM from a solid tumor, and meet other health criteria. The main goal is to find out how often side effects happen at different doses over one year.

Study design
This is an interventional study with a planned enrollment of 32 participants. It uses a dose escalation design, starting with an accelerated approach and then switching to a 3+3 design.
What's involved
You would receive DFO through an Ommaya reservoir twice a week during the first cycle, once a week during the second cycle, and then once every two weeks until your LM worsens, side effects become too strong, or death. Side effects will be monitored closely for the first 28 days of each dose level.
Compensation
Not stated in the trial record.
Follow-up
The study will assess side effects for one year during both the dose-finding and expansion phases.

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NCT05184816

A Study of Deferoxamine (DFO) in People With Leptomeningeal Metastasis

Recruiting
PHASE1Ages 18+InterventionalTreatment
Memorial Sloan Kettering Cancer Center
~32 participants
Updated 2026-07-14 on ClinicalTrials.gov
What's tested:Deferoxamine (DFO)

At a glance

Recruiting sites
7 of 7 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Frequency of dose-limiting toxicities (DLTs) during Phase Ia (Primary safety endpoint during dose-finding phase)
Measured over 1 year
+1 more outcome measured

Conditions

Leptomeningeal Metastases

Explore related trials

Metastatic Malignant Neoplasm in the LeptomeningesSolid Neoplasm

NCT05184816

Where you'd take part

This study runs at 7 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)

    Basking Ridge, New Jerseystudy coordinator listed

    Recruiting

  • Memorial Sloan Kettering Bergen (Limited Protocol Activities)

    Montvale, New Jerseystudy coordinator listed

    Recruiting

  • Memorial Sloan Kettering Cancer Center (All Protocol Activities)

    New York, New Yorkstudy coordinator listed

    Recruiting

  • Memorial Sloan Kettering Monmouth (Limited Protocol Activities)

    Middletown, New Jerseystudy coordinator listed

    Recruiting

  • Memorial Sloan Kettering Nassau (Limited Protocol Activities)

    Uniondale, New Yorkstudy coordinator listed

    Recruiting

  • Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities)

    Commack, New Yorkstudy coordinator listed

    Recruiting

  • Memorial Sloan Kettering Westchester (Limited Protocol Activities)

    Harrison, New Yorkstudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Jessica Wilcox, MD · PRINCIPAL_INVESTIGATOR · Memorial Sloan Kettering Cancer Center

Who to contact

Jessica Wilcox, MD
[email protected]
212-639-7573
Email the study team

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Eligibility criteria

Inclusion

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
LM from any solid tumor malignancy (1a and 1b), that is either:
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
Recurrent: As evidenced by unequivocal radiographic progression on contrast-enhanced MRI, the development of newly or recurrently positive CSF cytology, or a clinically-relevant rise in CSF CTCs at the discretion of the treating Investigator. There are no restrictions on the number of recurrences.
Persistent: As evidenced by any detectable disease (abnormal leptomeningeal enhancement on contrast-enhanced MRI; positive, suspicious, or atypical cytology; positive CSF CTCs; extrinsic cells on CSF cell count differential; or clinical symptoms attributed to LM) after receiving LM-directed radiation or systemic therapy. This includes patients with stable or partially responding LM who, in the opinion of the investigator, would benefit from additional LM-directed therapy.
Confirmation of solid tumor malignancy (phase 1a and 1b) may be made by histopathologic criteria of any primary or metastatic site. For patients that have not previously undergone internal pathology review at MSKCC, a pathology report confirming the primary malignancy is sufficient.
Patients can have concomitant parenchymal brain metastases at study entry as long as they do not require active treatment or have been previously treated.
Patients with seizure disorders, stable on appropriate antiepileptic therapies, are eligible for this trial.
Patients must have normal CSF flow dynamics at the clinical judgment of the treating investigator, with no obstructive hydrocephalus or ventriculoperitoneal (VP) or ventriculoatrial (VA) shunt.
Patients with isolated intracranial LM progression and stable extracranial disease may enroll on trial. If this population is receiving systemic treatment that is controlling their extracranial disease, they may remain on this regimen during study enrollment provided their LM progression occurred on this regimen.
For patients with both intracranial and extracranial disease progression at the time of study screening, necessitating change to their systemic tumor-directed therapy:
If the new systemic treatment of choice has known CNS activity at the discretion of the Principal Investigator, then they should be monitored on this new regimen for 21 days with confirmation of persistent LM (by neuraxial imaging and CSF reassessment) before enrolling on study.
If the new systemic treatment of choice has no known CNS activity at the discretion of the Principal Investigator, then they may start IT-DFO concurrently with the new systemic treatment.
Examples of systemic CNS-active treatments include but are not limited to: bevacizumab, temozolomide, carmustine, lomustine, etoposide, carboplatin, cisplatin, pemetrexed, doxorubicin, high-dose erlotinib, osimertinib, lorlatinib, lapatinib, tucatinib, capecitabine, dabrafenib, trametinib, vemurafenib, cobimetinib, ipilimumab, nivolumab, pembrolizumab, atezolizumab
Patients must have a functioning Ommaya reservoir prior to the first IT-DFO administration or be an appropriate surgical candidate for Ommaya reservoir placement and agree to Ommaya reservoir placement as standard of care prior to the first IT-DFO administration.
Patients that have screening laboratory values out of range, but not clinically significant, may be considered eligible on a case by case basis deemed by the clinical investigator. Adequate bone marrow and organ function is demonstrated by:
White blood cell (WBC) count ≥ 2.5 K/mcL or if this value is less, an exemption has been granted by the treating physician or primary investigator.
Absolute neutrophil count (ANC) ≥ 1.0 K/mcL
Platelet count ≥ 50 K/mcL at least 7 days from last platelet transfusion, or if this value is less, an exemption has been granted by the treating physician or primary investigator.
Hemoglobin (Hgb) ≥ 8 g/dL, or if this value is less, an exemption has been granted by the treating physician or primary investigator.
Serum creatinine ≤ 1.5 times the upper limit of normal (ULN) or if this value is more, an exemption has been granted by the treating physician or primary investigator.
Serum bilirubin ≤ 1.5 times the ULN; or total bilirubin ≤ 3 times the ULN with direct bilirubin within the normal range in patients with well documented Gilbert Disease or if this value is more, an exemption has been granted by the treating physician or primary investigator.
Serum alanine aminotransferase (ALT) and aspartate aminotransaminase (AST) ≤ 3 times the ULN, unless known hepatic disease wherein may be ≤ 5 times the ULN is acceptable. If this value is more, an exemption must be granted by the treating physician or primary investigator.
Women of child-bearing potential and sexually active males must commit to the use of effective contraception while on study.

Exclusion

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
Use of ascorbic acid or prochlorperazine within 2 weeks of first dose
Patients are not allowed to receive whole-brain radiation therapy or craniospinal radiation therapy during study enrollment.
Patients must not have any physical and/or psychiatric illness that would interfere with their compliance and ability to tolerate treatment as per the protocol.
Women may not be pregnant or breastfeeding
Known hypersensitivity orSpecial Characters

What this trial measures

  • Frequency of dose-limiting toxicities (DLTs) during Phase Ia (Primary safety endpoint during dose-finding phase)1 year

    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

  • Frequency of dose-limiting toxicities (DLTs) during Phase Ib (RP2D of IT-DFO in patients with LM from NSCLC)1 year

    Per CTCAE version 5.0