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

IMUNON

Status and phase: Withdrawn; Phase 2

Conditions: Small Cell Lung Cancer; Non-small Cell Lung Cancer; Painful Bone Metastases; Adenocarcinoma; Breast Carcinoma

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT01640847

106-10-201

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Arm RT: HIFU plus ThermoDox

Experimental group

Description:

Index lesion has been treated with EBRT and is currently painful, but these subjects have already received their maximum cumulative EBRT dose.

Treatment:

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

Arm NRT: HIFU plus ThermoDox

Experimental group

Description:

Subjects have no yet received any radiation to the index lesion.

Treatment:

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