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

NCT04791228 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2025-01-01

No results posted yet for this study

Summary

This is a pilot study of LTLD with MR-HIFU hyperthermia followed by ablation in subjects with refractory/relapsed solid tumors.

Conditions

  • Solid Tumors
  • Soft Tissue Sarcoma
  • Ewing Sarcoma
  • Malignant Epithelial Neoplasm
  • Rhabdomyosarcoma
  • Wilms Tumor
  • Hepatic Tumor
  • Germ Cell Tumor
  • Bone Metastases

Interventions

DEVICE

Magnetic Resonance-Guided High Intensity Focused Ultrasound

Magnetic resonance (MR)-guided high intensity focused ultrasound (HIFU) provides precise and controlled delivery of heat by focusing ultrasound energy inside a lesion using an external applicator without the need for a scalpel or needle. Additional therapeutic advantages of this modality include its range of bioeffects, including both high temperature tumor ablation via coagulative necrosis, and effects of lower temperature, mild hyperthermia that can help to enhance local drug delivery to tumors. Both tumor ablation and hyperthermia may be employed to potentiate the effects of chemotherapy.

DRUG

Lyso-thermosensitive Liposomal Doxorubicin

LTLD combines doxorubicin with lyso-thermosensitive liposomes that can selectively deliver drug to tumors and when exposed to temperatures greater than 40°C, rapidly and locally releases doxorubicin in high concentrations from systemically administered LTLD. If combined with hyperthermia, doxorubicin will be released in the heated tumor margins and in any areas within the tumor that were not completely ablated and increase the likelihood of complete tumor necrosis. LTLD will extend tumor cell death to the hyperthermic regions in the peri-ablation zones and minimize the possibility of incomplete ablation or tumor recurrence.

Sponsors & Collaborators

  • Children's National Research Institute

    lead OTHER

Principal Investigators

  • AeRang Kim, MD, PhD · Children's National Research Institute

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-11-10
Primary Completion
2024-12-23
Completion
2024-12-23
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04791228 on ClinicalTrials.gov