Percutaneous Cryoablation in Treating Patients With Painful Bone Metastases

Inclusion Criteria

• •DISEASE CHARACTERISTICS:
• •Histologically or cytologically confirmed metastatic solid tumor involving or abutting bone (index lesion)
• •* If the nature of the metastatic disease has been previously documented, index lesion to be treated does not require further documentation (i.e., biopsy)
• •Pain either refractory to standard care (chemotherapy, radiotherapy, surgery, or analgesics) or patient is considered a poor candidate for conventional therapies
• •* Radiation oncology consult is required if the patient is considered clinically to be a candidate for conventional palliative radiotherapy
• •* Surgical oncology consult is required if the patient is considered clinically to be a candidate for conventional surgical treatment or is considered at risk for complications resulting from potential fracture
• •Initial pain score ≥ 4 on a scale of 0-10 for the question "Please rate your pain by circling the one number that best describes your pain at its worst in the past 24 hours" on the Cleeland Brief Pain Inventory
• •* Pain from ≤ 2 sites of metastatic disease
• •No lesions with evidence for impending fracture involving a weight-bearing bone (\> 50% loss of cortical bone at the site)
• •PATIENT CHARACTERISTICS:
• •Life expectancy ≥ 2 months
• •Platelet count ≥ 75,000/mm³
• •ANC \> 1,500/mm³ (for patients who have recently been treated with chemotherapy)
• •INR ≤ 1.2
• •Not pregnant or nursing
• •Negative pregnancy test
• •PRIOR CONCURRENT THERAPY:
• •More than 3 weeks since prior radiotherapy
• •More than 3 weeks since initiation of a new chemotherapy regimen, including bisphosphonates
• •More than 7 days since prior antiplatelet medications or clopidogrel
• •More than 3 days since prior acetylsalicylic acid (aspirin), ibuprofen, or other NSAIDs
• •No prior treatment of the portion of a lesion within 0.5 cm of the spinal cord or brain, within 0.5 cm of a large abdominal vessel such as the aorta or inferior vena cava, or within 1 cm of bowel or bladder
• •No prior radiofrequency ablation for pain palliation of the same lesion
• •No concurrent regular or low molecular weight heparin or other anticoagulants