The purpose of this study is to determine whether Doxil (liposomal doxorubicin) given prior to MR-HIFU Hyperthermia is safe for the treatment of pediatric and young adult patients with recurrent and refractory solid tumors.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
50mg IV every 4 weeks
Hyperthermia to 42C for 30 minutes every 4 weeks
UT Southwestern Medical Center/Children's Medical Center
Dallas, Texas, United States
Rate of dose limiting toxicities (DLTs) during cycle 1 of therapy with MR-HIFU hyperthermia directed liposomal doxorubicin
Dose limiting toxicities are generally CTCAE v4.03 grade 3-5 toxicities with specific exceptions detailed in the protocol.
Time frame: 4 weeks
Terminal half-life (T1/2) of Doxil when delivered with MR-HIFU hyperthermia
Time frame: 48 hours following first dose
Volume of distribution (L/m2) of Doxil when delivered with MR-HIFU hyperthermia
Time frame: 48 hours following first dose
Clearance (mL/min) of Doxil when delivered with MR-HIFU hyperthermia
Time frame: 48 hours following first dose
Adverse events associated with Doxil when administered in combination with MR-HIFU hyperthermia
Time frame: 6 months
Percentage of patients with relapsed or refractory solid tumors treated with MR-HIFU hyperthermia and Doxil who demonstrate disease progression at a MR-HIFU treated lesion
Time frame: Through study completion, an average of 1 year
Tumor response to MR-HIFU with liposomal doxorubicin
Time frame: 6 months
Percentage of patients treated with MR-HIFU hyperthermia who are able to receive hyperthermia (41-45C) to greater than 75% of the predetermined treatment volume for greater than 75% of the planned treatment duration
Time frame: Day 1
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