HIFU Hyperthermia With Liposomal Doxorubicin (DOXIL) for Relapsed or Refractory Pediatric and Young Adult Solid Tumors

Withdrawn before enrolling · Phase 1

Conditions studied: Rhabdomyosarcoma, Neuroblastoma, Sarcoma, Sarcoma, Ewing, Osteosarcoma, Desmoid

In brief

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.

Key facts

Study ID: NCT02557854
Run by: Theodore Laetsch
People needed: 0
Starts: 2016-12-01
Expected to finish: 2019-03-16
Last updated by the study team: 2019-03-19

Who can join

Age: 1 and older, up to 40. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Age 1-40 years
Histologically confirmed malignant extra-cranial solid tumor or demoid fibromatosis
The subject's tumor must have relapsed after or failed to respond to frontline therapy and there must be no other known curative therapies available. Patients with desmoid fibromatosis must have relapsed after or failed to respond to at least one prior line of therapy, and in the opinion of the treating physician surgical resection of the tumor must not be possible without an amputation or other surgery predicted to result in an unacceptable functional deficit.
Subject must have a life expectancy of > 8 weeks
Karnofsky performance status > 50% for patients >16 years of age, or Lansky performance status > 50% for patients < 16 years of age.
The subject must have at least 1 measurable target lesion >10mm in longest dimension that is in an anatomic location treatable by MR-HIFU. Note that for this study, lesions in bone WILL be considered measurable provided they meet the other criteria by RECIST and are confirmed to be metabolically active on baseline studies by either MIBG uptake (for neuroblastomas) or PET avidity. Target lesions should be located so that they can be adequately heated by a hyperthermia treatment cell with a diameter of up to 58 mm, centered at a depth of 35 to 80 mm from the skin. There should be no staples, implants, extensive scarring, or other highly ultrasound absorbing or reflecting tissue in the expected beam path. For the first 5 patients enrolled on this study only, the lesion must be located in the extremities or pelvis to be considered treatable by MR-HIFU.
The subject must have recovered from the acute toxic effects of all prior therapy with the exception of alopecia. The following time must have elapsed from the last dose of the following medications to study enrollment:
myelosuppressive chemotherapy 14 days
hematopoetic growth factors 7 days (14 days for Neulasta)
biologic agent 7 days
monoclonal antibody 3 half-lives
immunotherapy (ie tumor vaccines) 42 days
palliative small port XRT 14 days
substantial bone marrow XRT 6 weeks
stem cell transplant or infusion without TBI 12 weeks
total body irradiation (TBI) 24 weeks
Adequate organ and marrow function as defined below:
absolute neutrophil count ≥ 1,000/mcL
platelets ≥ 75,000/mcl (without transfusion for 7 days)
hemoglobin > 8g/dL (may receive transfusions)
total bilirubin < 1.5 mg/dL
ALT(SPGT) < 225 U/L (45 U/L defined as ULN)
creatinine clearance or radioisotope GFR > 70 mL/min/1.73m2 OR a serum creatinine (mg/dL) less than or equal to the following:
Age (yrs)-----Male (mg/dL)-----Female (mg/dL)
1-1.99----------0.6------------------0.6

You may not qualify if…

Subjects may not be receiving any other investigational agents or anticancer therapies.
Subjects with known active brain metastases will be excluded from this clinical trial. Patients with brain metastases that have been treated and stable for > 30 days following treatment will be eligible.
Subjects who have received prior Doxil and progressed on this therapy are not eligible, but subjects may have received prior doxorubicin.
Subjects with a history of tumor progression within 30 days of anthracycline administration are not eligible. However, subjects who have previously received an anthracycline and subsequently relapse greater than 30 days after their most recent prior dose of anthracycline will be eligible.
History of allergic reactions attributed to doxorubicin or Doxil
Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
Subjects must not be pregnant or nursing due to the potential for congenital abnormalities and the potential of this regimen to harm nursing infants.
Subjects with a contraindication to MR-HIFU
Subjects with conditions that carry high anesthetic risk in the opinion of the treating anesthesiologist are not eligible (i.e. subjects with significant airway compression by tumor or craniofacial abnormalities)

Where it is running

UT Southwestern Medical Center/Children's Medical Center — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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