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Anti-tumor antibiotic

Lyso-thermosensitive liposomal doxorubicin for Liver Cancer

Phase 1
Waitlist Available
Led By AeRang Kim, MD, PhD
Research Sponsored by AeRang Kim
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 18 weeks
Awards & highlights

Study Summary

This trial is testing a new cancer treatment combining two existing treatments, to see what dosage is safe and effective for children with various types of solid tumors that have not responded to other treatments.

Eligible Conditions
  • Liver Cancer
  • Soft Tissue Sarcoma
  • Neuroblastoma
  • Germ Cell Tumors
  • Wilms Tumor
  • Osteosarcoma
  • Rhabdomyosarcoma
  • Pediatric Cancer
  • Solid Tumors
  • Ewing Sarcoma

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 18 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 18 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Feasibility of treatment
Maximum tolerated dose of LTLD
Pharmacokinetics of LTLD
+1 more
Secondary outcome measures
Antitumor Activity of the Treatment
Determine the Changes in Pharmacodynamic Immune Markers in Participants
Social Impact of the Treatment on Participants

Trial Design

2Treatment groups
Experimental Treatment
Group I: Part BExperimental Treatment2 Interventions
LTLD at dose determined from Part A will be administered intravenously on day 1 of every 21 day cycle. MR-HIFU induced MHT will follow immediately post LTLD infusion for one hour to target area with target temperatures of 40-45°C. Patients may receive up to a total of 6 cycles
Group II: Part AExperimental Treatment2 Interventions
LTLD will be administered intravenously in combination with MR-HIFU ablation on day 1 of every 21 day cycle. There will be two potential dose escalation of LTLD with highest dose not to exceed the adult recommended MTD. Patients may receive up to a total of 6 cycles.

Find a Location

Who is running the clinical trial?

AeRang KimLead Sponsor
1 Previous Clinical Trials
14 Total Patients Enrolled
AeRang Kim, MD, PhDPrincipal Investigator - Children's National Research Institute
Children's National Research Institute
5 Previous Clinical Trials
74 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
Expert Opinion on Emerging DrugsJournal
An Update on Emerging Drugs in Osteosarcoma: Towards Tailored Therapies?
Hattinger, Claudia Maria, Maria Pia Patrizio, Federica Magagnoli, Silvia Luppi, and Massimo Serra. 2019. “An Update on Emerging Drugs in Osteosarcoma: Towards Tailored Therapies?”. Expert Opinion on Emerging Drugs. Informa UK Limited. doi:10.1080/14728214.2019.1654455.
clinicaltrials.govStudy
A Phase I Study of Lyso-thermosensitive Liposomal Doxorubicin and MR-HIFU for Pediatric Refractory Solid Tumors
AeRang Kim 2016. "A Phase I Study of Lyso-thermosensitive Liposomal Doxorubicin and MR-HIFU for Pediatric Refractory Solid Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02536183.
~0 spots leftby Apr 2025
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