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OncoMatch/Clinical Trials/NCT05184816

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

Is NCT05184816 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies Deferoxamine (DFO) for leptomeningeal metastases.

Phase 1RecruitingMemorial Sloan Kettering Cancer CenterNCT05184816Data as of May 2026

Treatment: Deferoxamine (DFO)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.

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Extracted eligibility criteria

Disease stage

Metastatic disease required

Performance status

ECOG OR KPS 0–2

Prior therapy

Cannot have received: CNS-directed irradiation

Exception: within 7 days of first dose of IT-DFO

Any CNS-directed irradiation within 7 days of first dose of IT-DFO.

Cannot have received: intrathecal or systemic therapy designed to treat LM

Exception: with ongoing acceptable control of their LM

Patients receiving other therapy (either intrathecal or systemic) designed to treat their LM, with ongoing acceptable control of their LM.

Cannot have received: systemic iron chelators

Exception: within 4 weeks of first dose

Use of any systemic iron chelators within 4 weeks of first dose

Cannot have received: ascorbic acid or prochlorperazine (ascorbic acid, prochlorperazine)

Exception: within 2 weeks of first dose

Use of ascorbic acid or prochlorperazine within 2 weeks of first dose

Lab requirements

Blood counts

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.

Kidney function

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.

Liver function

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. 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.

Adequate bone marrow and organ function is demonstrated by: WBC count ≥ 2.5 K/mcL... Serum creatinine ≤ 1.5 times the upper limit of normal (ULN)... Serum bilirubin ≤ 1.5 times the ULN... ALT and AST ≤ 3 times the ULN, unless known hepatic disease wherein may be ≤ 5 times the ULN is acceptable.

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities) · Basking Ridge, New Jersey
  • Memorial Sloan Kettering Monmouth (Limited Protocol Activities) · Middletown, New Jersey
  • Memorial Sloan Kettering Bergen (Limited Protocol Activities) · Montvale, New Jersey
  • Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities) · Commack, New York
  • Memorial Sloan Kettering Westchester (Limited Protocol Activities) · Harrison, New York

Showing up to 5 US sites. See all sites on ClinicalTrials.gov →

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