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

PHASE2WithdrawnINTERVENTIONAL
0
Timeline

Start Date

November 10, 2022

Primary Completion Date

December 23, 2024

Study Completion Date

December 23, 2024

Conditions
Solid TumorsSoft Tissue SarcomaEwing SarcomaMalignant Epithelial NeoplasmRhabdomyosarcomaWilms TumorHepatic TumorGerm Cell TumorBone 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."

Trial Locations (1)

20010

Children's National Hospital, Washington D.C.

All Listed Sponsors
lead

Children's National Research Institute

OTHER