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Phase II Trial of Phillips MRI-Guided High Intensity Focused Ultrasound (Sonalleve) and Lyso-thermosensitive Liposomal Doxorubicin (ThermoDox) for Palliation of Painful Bone Metastases


Phase 2
18 Years
N/A
Not Enrolling
Both
Painful Bone Metastases, Breast Carcinoma,, Non-small Cell Lung Cancer,, Small Cell Lung Cancer,, Adenocarcinoma

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Trial Information

Phase II Trial of Phillips MRI-Guided High Intensity Focused Ultrasound (Sonalleve) and Lyso-thermosensitive Liposomal Doxorubicin (ThermoDox) for Palliation of Painful Bone Metastases


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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Rate of complete pain response

Outcome Time Frame:

12 months

Safety Issue:

No

Principal Investigator

Nicholas Borys, M.D.

Investigator Role:

Study Director

Investigator Affiliation:

Celsion

Authority:

United States: Food and Drug Administration

Study ID:

106-10-201

NCT ID:

NCT01640847

Start Date:

Completion Date:

Related Keywords:

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

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