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Clinical Trials/NCT01640847
NCT01640847
Withdrawn
Phase 2

Phase II Trial of Phillips MRI-Guided High Intensity Focused Ultrasound (Sonalleve) and Lyso-thermosensitive Liposomal Doxorubicin (ThermoDox) for Palliation of Painful Bone Metastases

Imunon0 sitesJuly 2012
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ConditionsPainful Bone MetastasesBreast CarcinomaNon-small Cell Lung CancerSmall Cell Lung CancerAdenocarcinoma
InterventionsHigh Intensity Focused Ultrasound (HIFU) in combination with ThermoDox
DrugsHigh Intensity Focused Ultrasound (HIFU) in combination with ThermoDox

Overview

Phase
Phase 2
Intervention
High Intensity Focused Ultrasound (HIFU) in combination with ThermoDox
Conditions
Painful Bone Metastases
Sponsor
Imunon
Primary Endpoint
Rate of complete pain response
Status
Withdrawn
Last Updated
9 years ago
OverviewInvestigatorsEligibility CriteriaArms & InterventionsOutcomesSimilar Trials

Overview

Brief Summary

This study will evaluate treatment with High Intensity Focused Ultrasound (HIFU)in combination with ThermoDox (liposomal doxorubicin) is safe and effective in reducing pain for patients with painful bone metastases.

Registry
clinicaltrials.gov
Start Date
July 2012
End Date
July 2013
Last Updated
9 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Imunon
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • •Histological confirmation of breast carcinoma, non-small cell lung cancer, small cell lung cancer, or adenocarcinoma of the prostate
  • •Bone metastases index lesion in the ribs, clavicle, scapula, upper extremities, pelvis, or posterior aspects of the lumbar vertebra L3-L5 or sacral S1-S
  • •Patients will have failed at least one prior attempt or will not be eligible for external beam radiation therapy (EBRT)

Exclusion Criteria

  • •Greater than 450 mg/m2 of prior free doxorubicin and/or non-heat activated liposomal doxorubicin
  • •LVEF \< 50%
  • •Significant Cardiac History
  • •Brain Metastases
  • •Contraindication for MR imaging (as incompatible implanted metallic device, weight \>250 lbs etc) or known intolerance or allergy to MRI contrast agents.

Arms & Interventions

Arm NRT: HIFU plus ThermoDox

Subjects have no yet received any radiation to the index lesion.

Intervention: High Intensity Focused Ultrasound (HIFU) in combination with ThermoDox

Arm RT: HIFU plus ThermoDox

Index lesion has been treated with EBRT and is currently painful, but these subjects have already received their maximum cumulative EBRT dose.

Intervention: High Intensity Focused Ultrasound (HIFU) in combination with ThermoDox

Outcomes

Primary Outcomes

Rate of complete pain response

Time Frame: 12 months

Secondary Outcomes

  • Adverse Events(3 months)

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