Status:
COMPLETED
Safety and Efficacy of Cryoablation for the Palliation of Painful Bone Metastases
Lead Sponsor:
Boston Scientific Corporation
Conditions:
Pain
Neoplasm Metastasis
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This study will evaluate the safety and efficacy of cryoablation therapy for relief of pain associated with metastatic bone tumors.
Detailed Description
Patients with painful bone metastases who meet the eligibility criteria and who have been determined to be an appropriate candidate for cryoablation therapy will be offered enrollment into the study. ...
Eligibility Criteria
Inclusion
- 18 years of age or older
- Metastatic bone disease with metastatic disease previously confirmed by prior biopsy; or Metastatic bone disease previously confirmed on imaging \[e.g. computed tomography (CT) or magnetic resonance imaging (MRI)\] with known (biopsied) primary disease (primary bone cancer is excluded)
- Current analgesic therapies have failed OR the subject is experiencing intolerable side effects
- Unremitting pain that resulted in a return visit to the oncologist. The 'worst pain' in the last 24 hours must be reported to be 4 or above on a scale of 0 (no pain) to 10 (pain as bad as subject can imagine) despite pharmaceutical pain management
- Pain must be from one or two painful metastatic sites in the bone that is amenable to cryoablation with CT or MRI (additional less painful metastatic sites may be present)
- Pain from the reported one or two metastatic sites must correlate with an identifiable tumor on CT, MRI, or ultrasound (US) imaging
- Tumors must be suitable for cryoablation
- Cryoablation should be performed within 14 days of baseline evaluations
- Stable use of hormonal therapy (no changes within 4 weeks prior to the cryoablation procedure)
- Stable use of pain medications (no changes within 2 weeks prior to the cryoablation procedure)
- ECOG (Eastern Cooperative Oncology Group) scale performance status 0-3
- Life expectancy ≥ 2 months
- Platelet count \>50,000/mm³ within 6 weeks screening
- INR (International Normalized Ratio) \<1.5 within 6 weeks screening
- No debilitating medical or psychiatric illness that would preclude giving informed consent or receiving optimal treatment and follow-up
- If taking antiplatelet or anticoagulation medication, it must be able to be discontinued prior to the procedure for an appropriate amount of time (e.g., aspirin, ibuprofen, low molecular weight heparin preparations)
- Clinically suitable for cryoablation therapy
Exclusion
- Leukemia, lymphoma, and myeloma
- Tumor involves a weight-bearing long bone of the lower extremity with the tumor causing \> 50% loss of cortical bone
- Has undergone prior ablation treatment of the index tumor
- Prior radiation therapy of the index tumor \<3 weeks prior to screening
- Index tumor causing clinical or radiographic evidence of spinal cord or cauda equina compression/effacement
- Anticipated treatment of the index tumor that would require iceball formation within 1.0 cm of the spinal cord, brain, other critical nerve structure, large abdominal vessel such as the aorta or inferior vena cava, bowel, or bladder
- Surgery at the tumor site or surgery involving the cryoablation-treated tumor (index tumor)
- Index tumor involves the skull (treatment of other painful tumors in subjects with skull tumors is not excluded)
- Patient currently with neutropenia (absolute neutrophil count \<1000) within 6 weeks screening
- Uncontrolled coagulopathy or bleeding disorders
- Currently pregnant, nursing, or wishing to become pregnant during the study
- Active, uncontrolled infection
- Serious medical illness, including any of the following: uncontrolled congestive heart failure, uncontrolled angina, myocardial infarction, cerebrovascular event within 6 months prior to study entry
- Concurrent participation in other experimental studies that could affect the primary endpoint
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2015
Estimated Enrollment :
29 Patients enrolled
Trial Details
Trial ID
NCT01461265
Start Date
November 1 2011
End Date
April 1 2015
Last Update
July 16 2021
Active Locations (4)
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1
Karmanos Cancer Institute
Detroit, Michigan, United States, 48201
2
University of Texas M.D. Anderson Cancer Center
Houston, Texas, United States, 77030
3
University of British Columbia
Vancouver, British Columbia, Canada, V5Z 1L8
4
University Hospital of Strasbourg
Strasbourg, France, F-67091