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

February 3, 2017 updated by: Imunon

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

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Rate of complete pain response
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Adverse Events
Time Frame: 3 months
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Imunon

Collaborators

Philips Healthcare

Investigators

  • Study Director: Nicholas Borys, M.D., Imunon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2012

Primary Completion (Actual)

June 1, 2013

Study Completion (Actual)

July 1, 2013

Study Registration Dates

First Submitted

July 12, 2012

First Submitted That Met QC Criteria

July 13, 2012

First Posted (Estimate)

July 16, 2012

Study Record Updates

Last Update Posted (Estimate)

February 7, 2017

Last Update Submitted That Met QC Criteria

February 3, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 106-10-201

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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