Painful Bone MetastasesPhase 2NCT01640847
MRI Guided High Intensity Focused Ultrasound (HIFU) and ThermoDox for Palliation of Painful Bone Metastases
A Phase 2 study testing High Intensity Focused Ultrasound (HIFU) in combination with ThermoDox in people with Painful Bone Metastases and Breast Carcinoma, run by Imunon.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Painful Bone Metastases, Breast Carcinoma, Non-small Cell Lung Cancer
- What is being tested?
- High Intensity Focused Ultrasound (HIFU) in combination with ThermoDox
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jul 2012to Jul 2013
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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.
About this study
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
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.
- Conditions
- Painful Bone Metastases, Breast Carcinoma, Non-small Cell Lung Cancer, Small Cell Lung Cancer, Adenocarcinoma
- Being tested
- High Intensity Focused Ultrasound (HIFU) in combination with ThermoDox
- Keywords
- Painful bone metastases, Bone Cancer, Bone Cancer Pain, Patients with
- Medical subject headings
- Breast Neoplasms, Carcinoma, Non-Small-Cell Lung, Small Cell Lung Carcinoma, Adenocarcinoma, Bone Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Intensity Focused Ultrasound (HIFU) in combination with ThermoDoxDrug
| Study group | Role | What they receive |
|---|---|---|
| Arm RT: HIFU plus ThermoDox | Experimental | Index lesion has been treated with EBRT and is currently painful, but these subjects have already received their maximum cumulative EBRT dose. Receives: Drug: High Intensity Focused Ultrasound (HIFU) in combination with ThermoDox |
| Arm NRT: HIFU plus ThermoDox | Experimental | Subjects have no yet received any radiation to the index lesion. Receives: Drug: High Intensity Focused Ultrasound (HIFU) in combination with ThermoDox |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of complete pain response
Measured: 12 months
Secondary outcomes (1)
Adverse Events
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2012 (estimated)
- Study startJul 2012
- Primary completionJun 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Painful Bone MetastasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imunon
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Philips Healthcare
- Responsible party
- Sponsor
- Investigators
- Nicholas Borys, M.D., Study director, Imunon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01640847
- Sponsor's protocol ID
- 106-10-201
- Status last verified
- Feb 2017
- First submitted
- 12 Jul 2012
- Last updated
- 7 Feb 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01640847
- Acronym / sponsor ID
- 106-10-201
- Conditions
- 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
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- ImunonIndustry (pharma, biotech, devices)
- Collaborators
- Philips Healthcare
- Study start
- Jul 2012
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 16 Jul 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm RT: HIFU plus ThermoDox | Experimental | Drug: High Intensity Focused Ultrasound (HIFU) in combination with ThermoDoxIndex 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 | Experimental | Drug: High Intensity Focused Ultrasound (HIFU) in combination with ThermoDoxSubjects have no yet received any radiation to the index lesion. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High Intensity Focused Ultrasound (HIFU) in combination with ThermoDox | Drug | Arm NRT: HIFU plus ThermoDox, Arm RT: HIFU plus ThermoDox |
Primary outcome
Rate of complete pain response
Time frame: 12 months
1 secondary outcome
Adverse Events
Time frame: 3 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicholas Borys, M.D. study director
Imunon
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing High Intensity Focused Ultrasound (HIFU) in combination with ThermoDox in people with Painful Bone Metastases and Breast Carcinoma, run by Imunon.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 7 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of complete pain response (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2017.