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Iron Chelator

Deferoxamine for Meningeal Carcinomatosis

Phase 1
Recruiting
Led By Adrienne Boire, MD
Research Sponsored by Memorial Sloan Kettering Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age ≥ 18 years on the day of consenting to study
ECOG performance status ≤ 2 or KPS ≥ 60
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights

Study Summary

This trial is testing the safety of giving deferoxamine (DFO) directly into the CSF to treat leptomeningeal metastasis from solid tumor cancer. The researchers will start with lower doses and increase until they find the highest dose that still causes few or mild side effects. If DFO is found to be safe, the researchers will then test it to see if it is an effective treatment for NSCLC.

Who is the study for?
This trial is for adults over 18 with leptomeningeal metastasis from solid tumors or NSCLC, who have a life expectancy of at least 8 weeks and can use effective contraception. They must be stable enough not to need immediate brain metastases treatment, able to handle an Ommaya reservoir (a device placed in the brain for drug delivery), and have normal CSF flow.Check my eligibility
What is being tested?
Researchers are testing Deferoxamine (DFO) given directly into the cerebrospinal fluid (CSF) to find a safe dose for treating leptomeningeal metastasis from solid tumor cancers. They aim to determine how DFO affects the body and its safety and effectiveness against non-small cell lung cancer-related metastasis.See study design
What are the potential side effects?
Potential side effects may include reactions related to intrathecal administration like headache, infection risk at the Ommaya reservoir site, possible changes in blood counts due to bone marrow suppression, and other typical drug-related adverse events such as nausea or allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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I can take care of myself but might not be able to do heavy physical work.
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My cancer, including lung cancer, has spread to the lining of my brain or spinal cord.
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My cancer has spread to my brain but is stable elsewhere.
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My cancer has spread to my brain and other parts of my body.
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I have a working Ommaya reservoir installed for treatment.
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My cancer is a solid tumor and it started in my lungs.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Frequency of dose-limiting toxicities (DLTs) during Phase Ia (Primary safety endpoint during dose-finding phase)
Frequency of dose-limiting toxicities (DLTs) during Phase Ib (RP2D of IT-DFO in patients with LM from NSCLC)
Secondary outcome measures
objective response rate (ORR)

Side effects data

From 2008 Phase 2 trial • 212 Patients • NCT00110617
28%
Pyrexia
26%
Cough
25%
Headache
21%
Vomiting
21%
Back pain
21%
Sickle cell anaemia with crisis
19%
Nausea
17%
Pain in extremity
17%
Diarrhoea
17%
Chest pain
15%
Abdominal pain
13%
Nasal congestion
13%
Upper respiratory tract infection
11%
Nasopharyngitis
11%
Urinary tract infection
9%
Oropharyngeal pain
9%
Abdominal pain upper
9%
Pharyngitis streptococcal
9%
Arthralgia
8%
Rash
8%
Pneumonia
8%
Abdominal discomfort
8%
Constipation
8%
Gastroenteritis
6%
Hypersensitivity
6%
Otitis media
6%
Transfusion reaction
6%
Wheezing
6%
Influenza
4%
Dyspnoea
4%
Rhinorrhoea
4%
Bacteraemia
4%
Pruritus
4%
Pulmonary embolism
4%
Sinusitis
4%
Dysuria
2%
Epistaxis
2%
Intracardiac thrombus
2%
Nervous system disorder
2%
Conduction disorder
2%
Poor peripheral circulation
2%
Sickle cell anaemia
2%
Adrenocortical insufficiency acute
2%
Device breakage
2%
Device malfunction
2%
Pain
2%
Cholelithiasis
2%
Catheter site infection
2%
Pyelonephritis
2%
Tooth abscess
2%
Dehydration
2%
Osteonecrosis
2%
Cerebrovascular accident
2%
Hypoxia
2%
Lung infiltration
2%
Superior vena caval occlusion
2%
Oedema peripheral
2%
Alanine aminotransferase increased
2%
Blood pressure diastolic increased
2%
Musculoskeletal pain
2%
Insomnia
2%
Oxygen saturation decreased
2%
Syncope
2%
Pregnancy
2%
Chills
2%
Acute chest syndrome
2%
Leukocytosis
2%
Cardio-respiratory arrest
2%
Transient ischaemic attack
2%
Staphylococcal bacteraemia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Period 2 Deferoxamine (DFO) Then ICL670
Period 1 Deferasirox (ICL670)
Period 1 Deferoxamine (DFO)
Period 2 Deferasirox (ICL670)

Trial Design

1Treatment groups
Experimental Treatment
Group I: Deferoxamine (DFO)Experimental Treatment1 Intervention
This study is an open-label, non-randomized, single-center, dose escalation phase 1a study of intrathecal deferoxamine (IT-DFO) in patients with leptomeningeal metastases (LM) from solid tumor malignancies, followed by a phase 1b dose expansion cohort at the recommended phase 2 dose (RP2D) in patients with LM from non-small cell lung cancer (NSCLC). Study objectives will include safety (1a/1b), pharmacokinetics (PK) and pharmacodynamics (PD) of IT-DFO (1a/1b), and preliminary anti-tumoral efficacy in patients with LM from NSCLC (1b).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Deferoxamine (DFO)
2005
Completed Phase 2
~220

Find a Location

Who is running the clinical trial?

Center for Experimental TherapeuticsUNKNOWN
F.M. KIRBY FOUNDATIONUNKNOWN
Memorial Sloan Kettering Cancer CenterLead Sponsor
1,930 Previous Clinical Trials
597,343 Total Patients Enrolled
2 Trials studying Metastases
384 Patients Enrolled for Metastases

Media Library

Deferoxamine (DFO) (Iron Chelator) Clinical Trial Eligibility Overview. Trial Name: NCT05184816 — Phase 1
Metastases Research Study Groups: Deferoxamine (DFO)
Metastases Clinical Trial 2023: Deferoxamine (DFO) Highlights & Side Effects. Trial Name: NCT05184816 — Phase 1
Deferoxamine (DFO) (Iron Chelator) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05184816 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is participation in this trial open to the public?

"Affirmative. Clinicaltrials.gov displays that this clinical investigation, which was established on December 22nd 2021, is actively recruiting patients. 35 participants must be found across 14 medical sites for the study to move forward."

Answered by AI

How many participants are accepted in this experiment?

"Affirmative. According to the information on clinicaltrials.gov, this research is currently recruiting participants. It was originally posted on December 22nd 2021 and was recently updated on October 31st 2022. 35 subjects need to be enrolled from 14 sites in total."

Answered by AI

How many centers are facilitating this research program?

"Currently, 14 local sites are welcoming patient enrollment. Besides Montvale, Basking Ridge and Harrison there are 11 other places to consider. To reduce travel times it is recommended that you select the closest clinical trial site to your residence."

Answered by AI

Are there any adverse effects associated with Deferoxamine (DFO)?

"Our team at Power has concluded that Deferoxamine (DFO) safety can be gauged to a 1, due to its being in the preliminary stages of clinical trials; limited data exists concerning both efficacy and safety."

Answered by AI
~8 spots leftby Dec 2024