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Anti-helminthic
Niclosamide for Pediatric Acute Myeloid Leukemia
Phase 1
Recruiting
Led By Kathleen M Sakamoto, MD, PhD
Research Sponsored by Stanford University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Serum creatinine ≤ 2.0 mg/dL or estimated creatinine clearance ≥ 30 mL/min (Cockcroft Gault) within 14 days prior to treatment initiation
Has previously failed all available and suitable therapies for AML Disease relapse or the presence of refractory disease after ≥ 2 cycles of chemotherapy must be documented by bone marrow (BM) examination demonstrating > 5% blasts in the BM not attributable to another cause. Administration of hydroxyurea 10 to 20 mg/kg/day PO (maximum 1000 mg PO BID) to control high WBC count is permitted.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 days
Awards & highlights
Study Summary
This trial is testing a new combination of drugs to treat kids with a certain kind of leukemia.
Who is the study for?
This trial is for pediatric patients aged 2-25 with relapsed/refractory acute myeloid leukemia (AML) who have failed previous therapies. Participants must have adequate liver and kidney function, a minimum expected lifespan of 4 weeks, and be able to take oral or nasogastric medications. They should not be pregnant or breastfeeding and must agree to use contraception.Check my eligibility
What is being tested?
The study tests the effects of increasing doses of Niclosamide combined with cytarabine in young patients with AML that has returned after treatment or hasn't responded to at least two chemotherapy cycles. The goal is to find an effective dose for this specific condition.See study design
What are the potential side effects?
While the side effects specific to Niclosamide in this context are not detailed here, potential risks may include typical chemotherapy-related issues such as nausea, fatigue, increased risk of infection due to low blood cell counts, liver toxicity, and allergic reactions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My kidney function is within the required range for the study.
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My AML has not responded to at least 2 chemotherapy treatments, confirmed by a bone marrow test.
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I am between 2 and 25 years old.
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I have been diagnosed with AML according to WHO standards.
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I can take medications by mouth or through a tube.
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My body surface area is 2.10 m2 or less.
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I am under 16 with a Lansky score over 50, or over 16 with a Karnofsky score over 50%.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 30 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Dose-limiting toxicity
Secondary outcome measures
Efficacy of niclosamide treatment clinical response
Side effects data
From 2021 Phase 2 trial • 73 Patients • NCT0439935621%
Nausea
9%
Skin rash
6%
Vomiting
100%
80%
60%
40%
20%
0%
Study treatment Arm
Control Group
Niclosamide- Experimental Group
Trial Design
4Treatment groups
Experimental Treatment
Group I: Niclosamide 800 mg/m2 /day divided BIDExperimental Treatment1 Intervention
Group II: Niclosamide 500 mg/m2 /day divided BIDExperimental Treatment1 Intervention
Group III: Niclosamide 250 mg/m2 /day divided BIDExperimental Treatment1 Intervention
Group IV: Niclosamide 1200 mg/m2 /day divided BIDExperimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Niclosamide
2017
Completed Phase 3
~2280
Find a Location
Who is running the clinical trial?
Stanford UniversityLead Sponsor
2,387 Previous Clinical Trials
17,334,034 Total Patients Enrolled
Kathleen M Sakamoto, MD, PhDPrincipal InvestigatorStanford University
1 Previous Clinical Trials
80 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My kidney function is within the required range for the study.I am between 2 and 25 years old.I have side effects from cancer treatment that haven't fully gone away, except for hair loss.I am a woman who can have children and have a recent negative pregnancy test.I have been diagnosed with AML according to WHO standards.My leukemia has spread to my brain but may be treatable with specific chemotherapy.I have an ongoing, untreated infection.I do not have any uncontrolled illnesses or social situations that would stop me from following the study's requirements.I can take medications by mouth or through a tube.My platelet count is at least 10,000/mm3, or I can receive a transfusion if it's lower.My bilirubin levels are within the normal range, or high due to Gilbert's syndrome.I cannot take niclosamide in its current forms.My AML has not responded to at least 2 chemotherapy treatments, confirmed by a bone marrow test.I do not have major issues with my digestive system that are uncontrolled.I am currently pregnant or breastfeeding.I have active hepatitis C.I agree to use effective birth control or practice abstinence during and for 30 days after the study.I have been diagnosed with a specific type of leukemia (APL).I had a bone marrow transplant and am currently experiencing severe GvHD symptoms.My body surface area is 2.10 m2 or less.I haven't had cancer treatment in the last 2 weeks, except for hydroxyurea for high WBC.I have a bleeding disorder like hemophilia.I am under 16 with a Lansky score over 50, or over 16 with a Karnofsky score over 50%.
Research Study Groups:
This trial has the following groups:- Group 1: Niclosamide 250 mg/m2 /day divided BID
- Group 2: Niclosamide 1200 mg/m2 /day divided BID
- Group 3: Niclosamide 500 mg/m2 /day divided BID
- Group 4: Niclosamide 800 mg/m2 /day divided BID
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many individuals are currently being monitored in this research endeavor?
"That is affirmative. Clinicaltrials.gov records that the recruitment process of this trial began on November 21st, 2022 and continues to date. 16 participants are required from two distinct sites in order for it to be completed successfully."
Answered by AI
What findings have been documented in past experiments regarding Niclosamide?
"Currently, 4 different medical trials are taking place to research Niclosamide. One of these is in Phase 3 with the majority based out of Palo Alto, California and 39 other sites across the globe."
Answered by AI
Who meets the criteria to enroll in this research endeavor?
"This trial is recruiting 16 individuals aged between 2 and 25 with a diagnosis of acute myelocytic leukemia. Applicants ought to meet the following prerequisites: failure of all applicable treatments, > 5% blasts in bone marrow not caused by another source, Body Surface Area (BSA) ≤ 2.10 m2 per Mostellar formula, ability to take PO or NG medications; Lansky score ≥ 50 for those under 16 years old or Karnofsky score ≥50 if above that age range, life expectancy exceeding 4 weeks, platelets ≥ 10 000/mm3 (platelet transfusion allowed), serum creatinine ≤ 2"
Answered by AI
Does Niclosamide pose any significant health risks to those who take it?
"The safety of Niclosamide has been partially established, giving it a score of 1. This is due to this trial being classified as Phase 1 and there being limited evidence on efficacy and safety."
Answered by AI
Does this trial include participants below the age of fifty-five?
"The boundaries for entrance into this trial are 2 years old and 25 years old, respectively."
Answered by AI
Are enrollees still being accepted for this investigation?
"According to clinicaltrials.gov, this medical test has been open for recruitment since November 21st 2022 and is still actively searching for participants."
Answered by AI
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