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

Non-small Cell Lung Cancer Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01640847
• Other study ID #: 106-10-201
• Status: Withdrawn
• Phase: Phase 2
• First received: July 12, 2012
• Last updated: February 3, 2017
• Start date: July 2012
• Est. completion date: July 2013

Study information

• Verified date: February 2017
• Source: Celsion
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Adenocarcinoma
• Bone Marrow Diseases
• Bone Neoplasms
• Breast Carcinoma
• Breast Neoplasms
• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Neoplasm Metastasis
• Neoplasms, Second Primary
• Non-small Cell Lung Cancer
• Pain
• Painful Bone Metastases
• Small Cell Lung Cancer
• Small Cell Lung Carcinoma

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Celsion	Philips Healthcare

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of complete pain response		12 months
Secondary	Adverse Events		3 months