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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Withdrawn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
Imunon
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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 >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

    First Posted
    July 12, 2012
    Last Updated
    February 3, 2017
    Sponsor
    Imunon
    Collaborators
    Philips Healthcare
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    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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