MRI Guided High Intensity Focused Ultrasound (HIFU) and ThermoDox for Palliation of Painful Bone Metastases
Primary Purpose
Painful Bone Metastases, Breast Carcinoma, Non-small Cell Lung Cancer
Status
Withdrawn
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
High Intensity Focused Ultrasound (HIFU) in combination with ThermoDox
Sponsored by
About this trial
This is an interventional treatment trial for Painful Bone Metastases focused on measuring Painful bone metastases, Bone Cancer, Bone Cancer Pain, Patients with
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-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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Arm RT: HIFU plus ThermoDox
Arm NRT: HIFU plus ThermoDox
Arm Description
Index lesion has been treated with EBRT and is currently painful, but these subjects have already received their maximum cumulative EBRT dose.
Subjects have no yet received any radiation to the index lesion.
Outcomes
Primary Outcome Measures
Rate of complete pain response
Secondary Outcome Measures
Adverse Events
Full Information
NCT ID
NCT01640847
First Posted
July 12, 2012
Last Updated
February 3, 2017
Sponsor
Imunon
Collaborators
Philips Healthcare
1. Study Identification
Unique Protocol Identification Number
NCT01640847
Brief Title
MRI Guided High Intensity Focused Ultrasound (HIFU) and ThermoDox for Palliation of Painful Bone Metastases
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 Type
Interventional
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Withdrawn
Study Start Date
July 2012 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
July 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Imunon
Collaborators
Philips Healthcare
4. Oversight
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Painful Bone Metastases, Breast Carcinoma, Non-small Cell Lung Cancer, Small Cell Lung Cancer, Adenocarcinoma
Keywords
Painful bone metastases, Bone Cancer, Bone Cancer Pain, Patients with
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm RT: HIFU plus ThermoDox
Arm Type
Experimental
Arm Description
Index lesion has been treated with EBRT and is currently painful, but these subjects have already received their maximum cumulative EBRT dose.
Arm Title
Arm NRT: HIFU plus ThermoDox
Arm Type
Experimental
Arm Description
Subjects have no yet received any radiation to the index lesion.
Intervention Type
Drug
Intervention Name(s)
High Intensity Focused Ultrasound (HIFU) in combination with ThermoDox
Primary Outcome Measure Information:
Title
Rate of complete pain response
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Adverse Events
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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-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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nicholas Borys, M.D.
Organizational Affiliation
Imunon
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
MRI Guided High Intensity Focused Ultrasound (HIFU) and ThermoDox for Palliation of Painful Bone Metastases
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