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

This study has suspended participant recruitment.
Sponsor:
Collaborator:
Phillips
Information provided by (Responsible Party):
Celsion
ClinicalTrials.gov Identifier:
NCT01640847
First received: July 12, 2012
Last updated: July 21, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention Phase
Painful Bone Metastases
Breast Carcinoma,
Non-small Cell Lung Cancer,
Small Cell Lung Cancer,
Adenocarcinoma
Drug: High Intensity Focused Ultrasound (HIFU) in combination with ThermoDox
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Celsion:

Primary Outcome Measures:
  • Rate of complete pain response [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Adverse Events [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 52
Arms Assigned Interventions
Experimental: HIFU plus Thermodox Drug: High Intensity Focused Ultrasound (HIFU) in combination with ThermoDox

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01640847

Sponsors and Collaborators
Celsion
Phillips
Investigators
Study Director: Nicholas Borys, M.D. Celsion
  More Information

No publications provided

Responsible Party: Celsion
ClinicalTrials.gov Identifier: NCT01640847     History of Changes
Other Study ID Numbers: 106-10-201
Study First Received: July 12, 2012
Last Updated: July 21, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Celsion:
Painful bone metastases
Bone Cancer
Bone Cancer Pain
Patients with

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Adenocarcinoma
Neoplasm Metastasis
Neoplasms, Second Primary
Small Cell Lung Carcinoma
Pain
Bone Neoplasms
Bone Marrow Diseases
Breast Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplastic Processes
Pathologic Processes
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Bone Diseases
Musculoskeletal Diseases
Hematologic Diseases
Breast Diseases

ClinicalTrials.gov processed this record on September 18, 2014