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

NCT01640847 | Withdrawn Phase 2

• 1 other identifier: 106-10-201
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

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

Outcome Measures

Primary Outcomes (1)

• Rate of complete pain response

  12 months

Secondary Outcomes (1)

• Adverse Events

  3 months

Study Arms (2)

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.

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.

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

Interventions

High Intensity Focused Ultrasound (HIFU) in combination with ThermoDox DRUG

Arm NRT: HIFU plus ThermoDox; Arm RT: HIFU plus ThermoDox

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Imunon: lead
• Philips Healthcare: collaborator

MeSH Terms

Conditions

Breast Neoplasms; Carcinoma, Non-Small-Cell Lung; Small Cell Lung Carcinoma; Adenocarcinoma; Bone Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Bone Diseases; Musculoskeletal Diseases

Study Officials

• Nicholas Borys, M.D.

  Imunon

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 12, 2012
• First Posted: July 16, 2012
• Study Start: July 1, 2012
• Primary Completion: June 1, 2013
• Study Completion: July 1, 2013
• Last Updated: February 7, 2017

Record last verified: 2017-02