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A Phase I Study of Lyso-thermosensitive Liposomal Doxorubicin and MR-HIFU for Pediatric Refractory Solid Tumors

2015-08-31 23:23:22 | BioPortfolio

Summary

This study is looking to determine the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) of lyso-thermosensitive liposomal doxorubicin (LTLD) administered in combination with MR-HIFU in children with relapsed/refractory solid tumors.

Description

This is phase 1 trial of LTLD with MR-HIFU induced heating in children and young adults with relapsed/refractory solid tumors.

Part A of the trial will be a traditional dose escalation study to determine the pediatric MTD/RP2D of LTLD combined with MR-HIFU ablation which allows for release of doxorubicin in the ablation zone and peri-ablation margins.

Part B of the trial will combine LTLD at the MTD/RP2D with MR-HIFU induced mild hyperthermia (MHT) in an expanded cohort.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Pediatric Cancer

Intervention

Magnetic resonance high intensity focused ultrasound, Lyso-thermosensitive liposomal doxorubicin

Location

Children's National Medical Center
Washington
District of Columbia
United States
20010

Status

Not yet recruiting

Source

Children's Research Institute

Results (where available)

View Results

Links

Published on BioPortfolio: 2015-08-31T23:23:22-0400

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