HIFU Hyperthermia With Liposomal Doxorubicin (DOXIL) for Relapsed or Refractory Pediatric and Young Adult Solid Tumors
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ClinicalTrials.gov Identifier: NCT02557854 |
Recruitment Status :
Withdrawn
(Lack of enrollment)
First Posted : September 23, 2015
Last Update Posted : March 19, 2019
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Tracking Information | |||
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First Submitted Date ICMJE | September 21, 2015 | ||
First Posted Date ICMJE | September 23, 2015 | ||
Last Update Posted Date | March 19, 2019 | ||
Actual Study Start Date ICMJE | December 2016 | ||
Actual Primary Completion Date | March 16, 2019 (Final data collection date for primary outcome measure) | ||
Current Primary Outcome Measures ICMJE |
Rate of dose limiting toxicities (DLTs) during cycle 1 of therapy with MR-HIFU hyperthermia directed liposomal doxorubicin [ Time Frame: 4 weeks ] Dose limiting toxicities are generally CTCAE v4.03 grade 3-5 toxicities with specific exceptions detailed in the protocol.
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Original Primary Outcome Measures ICMJE | Not Provided | ||
Change History | |||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Not Provided | ||
Current Other Pre-specified Outcome Measures | Not Provided | ||
Original Other Pre-specified Outcome Measures | Not Provided | ||
Descriptive Information | |||
Brief Title ICMJE | HIFU Hyperthermia With Liposomal Doxorubicin (DOXIL) for Relapsed or Refractory Pediatric and Young Adult Solid Tumors | ||
Official Title ICMJE | Not Provided | ||
Brief Summary | 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. | ||
Detailed Description | Not Provided | ||
Study Type ICMJE | Interventional | ||
Study Phase ICMJE | Phase 1 | ||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE |
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Study Arms ICMJE | Experimental: Doxil + MR-HIFU Hyperthermia
Liposomal doxorubicin (Doxil) 50mg IV every 4 weeks followed by Magnetic Resonance High Intensity Focused Ultrasound hyperthermia (MR-HIFU) with Philips Sonalleve System to 42C for 30 minutes every 4 weeks
Interventions:
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Publications * | Hattinger CM, Patrizio MP, Magagnoli F, Luppi S, Serra M. An update on emerging drugs in osteosarcoma: towards tailored therapies? Expert Opin Emerg Drugs. 2019 Sep;24(3):153-171. doi: 10.1080/14728214.2019.1654455. Epub 2019 Aug 14. | ||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||
Recruitment Status ICMJE | Withdrawn | ||
Actual Enrollment ICMJE |
0 | ||
Original Enrollment ICMJE | Not Provided | ||
Actual Study Completion Date ICMJE | March 16, 2019 | ||
Actual Primary Completion Date | March 16, 2019 (Final data collection date for primary outcome measure) | ||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 1 Year to 40 Years (Child, Adult) | ||
Accepts Healthy Volunteers ICMJE | No | ||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||
Listed Location Countries ICMJE | United States | ||
Removed Location Countries | |||
Administrative Information | |||
NCT Number ICMJE | NCT02557854 | ||
Other Study ID Numbers ICMJE | UTSW-HIFU-001 | ||
Has Data Monitoring Committee | Yes | ||
U.S. FDA-regulated Product | Not Provided | ||
IPD Sharing Statement ICMJE |
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Current Responsible Party | Theodore Laetsch, University of Texas Southwestern Medical Center | ||
Original Responsible Party | [Redacted] | ||
Current Study Sponsor ICMJE | Theodore Laetsch | ||
Original Study Sponsor ICMJE | [Redacted] | ||
Collaborators ICMJE | Not Provided | ||
Investigators ICMJE | Not Provided | ||
PRS Account | University of Texas Southwestern Medical Center | ||
Verification Date | March 2019 | ||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |