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

Sponsor

Celsion (Industry)

Overall Status

Withdrawn

CT.gov ID

NCT01640847

Collaborator

Philips Healthcare (Industry)

Enrollment

Arms

Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Painful Bone Metastases Breast Carcinoma Non-small Cell Lung Cancer Small Cell Lung Cancer Adenocarcinoma	Drug: High Intensity Focused Ultrasound (HIFU) in combination with ThermoDox	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jul 1, 2012

Actual Primary Completion Date :

Jun 1, 2013

Actual Study Completion Date :

Jul 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Drug: High Intensity Focused Ultrasound (HIFU) in combination with ThermoDox
Experimental: Arm NRT: HIFU plus ThermoDox Subjects have no yet received any radiation to the index lesion.	Drug: High Intensity Focused Ultrasound (HIFU) in combination with ThermoDox

Arm

Intervention/Treatment

Experimental: 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.

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

Experimental: Arm NRT: HIFU plus ThermoDox

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

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

Outcome Measures

Primary Outcome Measures

Rate of complete pain response [12 months]

Secondary Outcome Measures

Adverse Events [3 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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