Clinical trial NCT01461265: Safety and Efficacy of Cryoablation for the Palliation of Painful Bone Metastases
Official title: Cryoablation for the Palliation of Painful Bone Metastases
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Pain
Neoplasm Metastasis
Keywords: Painful bone metastases
Bone metastases
Metastatic bone tumors
Metastatic bone pain
Cryoablation
Cryotherapy
Cryosurgery
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2011-10-28
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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. Cryoablation is the process of destroying tissue by the application of extremely cold temperatures. Galil Medical Cryoablation Systems are used as a surgical tool in the fields of general surgery, dermatology (skin), neurology (nerves), chest surgery (including lung), Ears-Nose-Throat (ENT), gynecology, oncology (cancer), proctology (colon/rectal) and urology (kidney).

Patients agreeing to participate will read and sign an informed consent form and thus become subjects in the study. Treatment will be performed using a Galil Medical cryoablation system and Galil Medical cryoablation needles. Subjects will be followed for up to 24 weeks (6 months) for palliation of pain, quality of life and analgesic usage. Baseline and follow-up data will be collected for each subject via a web-based electronic data collection tool.

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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

Primary outcomes:
measure: Difference in worst pain scores
timeFrame: 24 weeks post-cryoablation
Secondary outcomes:
measure: Cryoablation retreatments
timeFrame: 24 weeks post-cryoablation
measure: Additional surgical treatments other than cryoablation
timeFrame: 24 weeks post-cryoablation
measure: Reduced analgesic usage
timeFrame: 24 weeks post-cryoablation
measure: Time to maximal palliation of pain after cryoablation
timeFrame: 24 weeks post-cryoablation
measure: Subject satisfaction with the amount palliation of pain obtained from cryoablation
timeFrame: 24 weeks post-cryoablation
measure: Number of adverse events
timeFrame: 30 days post-cryoablation
measure: Difference in average pain scores
timeFrame: 24 weeks post-cryoablation
measure: Time to recurrence of worst pain
timeFrame: 24 weks post-cryoablation
Other outcomes:
Locations:
city: Detroit
country: United States
facility: Karmanos Cancer Institute
state: Michigan
city: Houston
country: United States
facility: University of Texas M.D. Anderson Cancer Center
state: Texas
city: Vancouver
country: Canada
facility: University of British Columbia
state: British Columbia
city: Strasbourg
country: France
facility: University Hospital of Strasbourg
Study officials:
affiliation: Shands Medical Center, Jacksonville, FL
name: Jerry Matteo, MD
role: STUDY_CHAIR
References:
citation: Callstrom MR, Atwell TD, Charboneau JW, Farrell MA, Goetz MP, Rubin J, Sloan JA, Novotny PJ, Welch TJ, Maus TP, Wong GY, Brown KJ. Painful metastases involving bone: percutaneous image-guided cryoablation--prospective trial interim analysis. Radiology. 2006 Nov;241(2):572-80. doi: 10.1148/radiol.2412051247.
citation: Coleman RE. Management of bone metastases. Oncologist. 2000;5(6):463-70. doi: 10.1634/theoncologist.5-6-463.
citation: Goetz MP, Callstrom MR, Charboneau JW, Farrell MA, Maus TP, Welch TJ, Wong GY, Sloan JA, Novotny PJ, Petersen IA, Beres RA, Regge D, Capanna R, Saker MB, Gronemeyer DH, Gevargez A, Ahrar K, Choti MA, de Baere TJ, Rubin J. Percutaneous image-guided radiofrequency ablation of painful metastases involving bone: a multicenter study. J Clin Oncol. 2004 Jan 15;22(2):300-6. doi: 10.1200/JCO.2004.03.097.
citation: Callstrom MR, Charboneau JW, Goetz MP, Rubin J, Wong GY, Sloan JA, Novotny PJ, Lewis BD, Welch TJ, Farrell MA, Maus TP, Lee RA, Reading CC, Petersen IA, Pickett DD. Painful metastases involving bone: feasibility of percutaneous CT- and US-guided radio-frequency ablation. Radiology. 2002 Jul;224(1):87-97. doi: 10.1148/radiol.2241011613.
citation: Simon CJ, Dupuy DE. Percutaneous minimally invasive therapies in the treatment of bone tumors: thermal ablation. Semin Musculoskelet Radiol. 2006 Jun;10(2):137-44. doi: 10.1055/s-2006-939031. Epub 2006 Apr 5.
citation: Ullrick SR, Hebert JJ, Davis KW. Cryoablation in the musculoskeletal system. Curr Probl Diagn Radiol. 2008 Jan-Feb;37(1):39-48. doi: 10.1067/j.cpradiol.2007.05.001.