Safety and Efficacy of Cryoablation for the Palliation of Painful Bone Metastases

NCT01461265 | Completed Phase 1

• 1 other identifier: CUC10-BNE11
• Study Type: interventional
• Target: 29
• Locations: 3 countries
• Sites: 4

Brief Summary

This study will evaluate the safety and efficacy of cryoablation therapy for relief of pain associated with metastatic bone tumors.

Conditions

Pain; Neoplasm Metastasis

Keywords

Painful bone metastases; Bone metastases; Metastatic bone tumors; Metastatic bone pain; Cryoablation; Cryotherapy; Cryosurgery

Outcome Measures

Primary Outcomes (1)

• Difference in worst pain scores

  The endpoint for this study will be measured as follows: assessment of the effectiveness of cryoablation associated with palliation of pain in subjects with metastatic bone cancer by measuring the average difference of pre- and posttreatment worst pain in 24 hours from baseline to 24 hour, 1, 4, 12, and 24 week follow-up intervals as measured on the numeric 0 to 10 Brief Pain Inventory (BPI) scale.

  24 weeks post-cryoablation

Secondary Outcomes (8)

• Cryoablation retreatments

  24 weeks post-cryoablation

• Additional surgical treatments other than cryoablation

  24 weeks post-cryoablation

• Reduced analgesic usage

  24 weeks post-cryoablation

• Time to maximal palliation of pain after cryoablation

  24 weeks post-cryoablation

• Subject satisfaction with the amount palliation of pain obtained from cryoablation

  24 weeks post-cryoablation

Study Arms (1)

Cryoablation

OTHER

All subjects will have cryoablation on one or two painful metastatic bone tumors.

Procedure: Cryoablation

Interventions

Cryoablation PROCEDURE

For cryoablation in the palliation of painful bone metastases, subject preparation, anesthesia, intra-operative monitoring, and postoperative management are identical to those of standard cryoablation routinely performed at all clinical centers participating in this study and are at the discretion of the investigator.

Also known as: Cryotherapy, Cryosurgery, Visual-ICE Cryoablation System, SeedNet Cryoablation System, PresIce Cryoablation System, IceRod Cryoablation Needle, IceRod PLUS Cryoablation Needle, IceEDGE 2.4 Cryoablation Needle, IceSeed Cryoablation Needle, IceSphere Cryoablation Needle

Cryoablation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boston Scientific Corporation: lead

Study Sites (4)

Karmanos Cancer Institute

Detroit, Michigan, 48201, United States

Location

University of Texas M.D. Anderson Cancer Center

Houston, Texas, 77030, United States

Location

University of British Columbia

Vancouver, British Columbia, V5Z 1L8, Canada

Location

University Hospital of Strasbourg

Strasbourg, F-67091, France

Location

Related Publications (6)

• 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.

  PMID: 17057075 BACKGROUND

• Coleman RE. Management of bone metastases. Oncologist. 2000;5(6):463-70. doi: 10.1634/theoncologist.5-6-463.

  PMID: 11110597 BACKGROUND

• 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.

  PMID: 14722039 BACKGROUND

• 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.

  PMID: 12091666 BACKGROUND

• 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.

  PMID: 16598666 BACKGROUND

• 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.

  PMID: 18054665 BACKGROUND

MeSH Terms

Conditions

Pain; Neoplasm Metastasis; Bone Neoplasms

Interventions

Cryosurgery; Cryotherapy

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neoplastic Processes; Neoplasms; Pathologic Processes; Neoplasms by Site; Bone Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Ablation Techniques; Surgical Procedures, Operative; Therapeutics

Study Officials

• Jerry Matteo, MD

  Shands Medical Center, Jacksonville, FL

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 25, 2011
• First Posted: October 28, 2011
• Study Start: November 1, 2011
• Primary Completion: April 1, 2015
• Study Completion: April 1, 2015
• Last Updated: July 16, 2021

Record last verified: 2021-07

Locations

CA (1); FR (1); US (2)