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Chemotherapy

Thermodox + MR-HIFU for Cancer

Phase 2

Recruiting

Led By AeRang Kim, MD, PhD

Research Sponsored by Children's National Research Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

RENAL FUNCTION: Serum creatinine ≤ ULN for age/sex OR a creatinine clearance ≥60 mL/min/1.73 m2

PERFORMANCE STATUS: Lansky/Karnofsky performance level ≥ 50%

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at 1 day and 1 week after mr-hifu treatment on first 21-day cycle

Awards & highlights

Study Summary

This trial uses ultrasound and heat to treat cancer that hasn't responded to other treatments.

Who is the study for?

This trial is for individuals aged 12 or older with certain types of solid tumors that have not responded to standard treatments. Participants must be in a stable health condition, with specific requirements for blood cell counts and organ function. They should have at least one tumor accessible to HIFU treatment and no other curative options available.Check my eligibility

What is being tested?

The study tests the combination of LTLD (a type of chemotherapy) with MR-HIFU, which uses magnetic resonance imaging to guide focused ultrasound for heating and destroying cancer cells. The goal is to see if this approach is effective in treating relapsed or refractory solid tumors.See study design

What are the potential side effects?

Potential side effects include those commonly associated with doxorubicin such as nausea, vomiting, hair loss, mouth sores, and heart damage. The HIFU procedure may cause discomfort or pain at the target site, skin burns, or damage to nearby tissues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My kidney function is normal or near normal.

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I can do most activities but need help with some.

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My cancer returned or didn't respond to initial treatment, and no other curative treatments are available.

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My heart pumps well, with an ejection fraction over 50%.

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My blood tests show enough neutrophils and platelets without recent transfusions.

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My liver tests are within the required range.

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My cancer is confirmed through tissue examination.

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I am 12 years old or older.

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I have a tumor that can be reached with high-intensity focused ultrasound.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at the end of every 21-day cycle

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at the end of every 21-day cycle

This trial's timeline: 3 weeks for screening, Varies for treatment, and at the end of every 21-day cycle for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Primary objective 1: Response of treated target lesion(s) assessed by CT or MRI

Primary objective 2: The number of participants with treatment-related adverse events as assessed by the Common Terminology Criteria of Adverse Events (CTCAE) v.5

Other outcome measures

Exploratory objective 1: Response of non-target lesion(s) assessed by CT or MRI

Exploratory objective 2: Participant reported target tumor pain intensity assessed using the Numerical Rating Scale-11 (NRS-11)

Exploratory objective 3: Participant reported impact of pain on daily activities assessed using the PROMIS Pain Interference Scale (PROMIS-PI)

+1 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: All PatientsExperimental Treatment2 Interventions

LTLD 50 mg/m2 will be administered intravenously over 30 minutes on day 1 of every 21-day cycle. MR-HIFU hyperthermia will follow infusion (+/- 30 minutes) for one hour to a target area with a target temperature of 40-45°C followed by ablation therapy (>55°C). The HIFU hyperthermia regimen will have a duration of at least 60 minutes and will then be followed by ablation therapy. Patients may receive up to a total of 6 cycles. Subsequent treatment cycles may treat alternative target lesions. Disease status will be evaluated using standard imaging techniques (CT/MR) post each cycle.

0 / 9Eligibility criteria met

Find a Location

Who is running the clinical trial?

Children's National Research InstituteLead Sponsor

211 Previous Clinical Trials

208,143 Total Patients Enrolled

2 Trials studying Wilms Tumor

3,405 Patients Enrolled for Wilms Tumor

AeRang Kim, MD, PhDPrincipal InvestigatorChildren's National Research Institute

5 Previous Clinical Trials

62 Total Patients Enrolled

3 Trials studying Wilms Tumor

21 Patients Enrolled for Wilms Tumor

Media Library

Lyso-thermosensitive Liposomal Doxorubicin (Chemotherapy) Clinical Trial Eligibility Overview. Trial Name: NCT04791228 — Phase 2

Wilms Tumor Research Study Groups: All Patients

Wilms Tumor Clinical Trial 2023: Lyso-thermosensitive Liposomal Doxorubicin Highlights & Side Effects. Trial Name: NCT04791228 — Phase 2

Lyso-thermosensitive Liposomal Doxorubicin (Chemotherapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04791228 — Phase 2

Frequently Asked Questions

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

To what degree is All Patients considered to be a safe option for individuals?

"Our assessment at Power gave All Patients a score of 2 due to there being some evidence of safety but not yet any proof that the treatment works."

Answered by AI

For what is All Patients commonly prescribed?

"All Patients is widely prescribed for hodgkin's lymphoma and can be beneficial in managing carcinomas, bronchogenic issues, neuroblastom (nb), and sezary syndrome."

Answered by AI

Has a similar research project been instituted before?

"Since 1997, Alfacell has been researching All Patients; their initial trial involving 300 participants resulted in the drug's Phase 3 approval. Presently, there are 341 active studies for this medication spanning 1948 cities and 66 countries worldwide."

Answered by AI

Is there an ongoing recruitment of participants for this experiment?

"That is correct. According to clinicaltrials.gov, this medical trial has been recruiting since March 1st of 2023 and was most recently updated on January 31st of the same year. A total of 14 individuals are required for the study, which will be conducted at a single location."

Answered by AI

What is the aggregate number of participants enrolled in this research project?

"Affirmative, the records on clinicaltrials.gov reflect that this medical trial is in need of enrolment. It was first reported on March 1st 2023 and its information has been updated most recently on January 31st 2023. The study seeks 14 participants from one location."

Answered by AI

What other experiments have been conducted to assess the efficacy of treatments for All Patients?

"At the moment, 341 trials are being conducted for All Patients. Of these studies, 114 have progressed to Phase 3 and New york City is hosting the majority of them. For this treatment, there are 23187 active sites globally."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Pilot Study of Thermodox and MR-HIFU for Treatment of Relapsed Solid Tumors

AeRang Kim 2022. "A Pilot Study of Thermodox and MR-HIFU for Treatment of Relapsed Solid Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04791228.

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