MRI Guided High Intensity Focused Ultrasound (HIFU) and ThermoDox for Palliation of Painful Bone Metastases

Phase 2

Withdrawn

• Conditions: Small Cell Lung Cancer; Painful Bone Metastases; Breast Carcinoma; Non-small Cell Lung Cancer; Adenocarcinoma
• Interventions: Drug: High Intensity Focused Ultrasound (HIFU) in combination with ThermoDox

• Registration Number: NCT01640847
• Lead Sponsor: Imunon

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-07
• Study First Submitted: 2012-07-12
• Study First Submitted QC: 2012-07-13
• Study First Posted: 2012-07-16
• Primary Completion: 2013-06
• Study Completion: 2013-07
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-03
• Last Update Posted: 2017-02-07

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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-S5.
• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Arm RT: HIFU plus ThermoDox	High Intensity Focused Ultrasound (HIFU) in combination with ThermoDox	Index lesion has been treated with EBRT and is currently painful, but these subjects have already received their maximum cumulative EBRT dose.
Arm NRT: HIFU plus ThermoDox	High Intensity Focused Ultrasound (HIFU) in combination with ThermoDox	Subjects have no yet received any radiation to the index lesion.

Primary Outcome Measures

Name	Time	Method
Rate of complete pain response	12 months

Secondary Outcome Measures

Name	Time	Method
Adverse Events	3 months