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Percutaneous Cryoablation in Treating Patients With Painful Bone Metastases

Primary Purpose

Metastatic Cancer, Pain, Unspecified Adult Solid Tumor, Protocol Specific

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
questionnaire administration
cryosurgery
pain therapy
quality-of-life assessment
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metastatic Cancer focused on measuring bone metastases, pain, unspecified adult solid tumor, protocol specific

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Mayo Clinic - Jacksonville
  • University of Michigan Comprehensive Cancer Center
  • Barbara Ann Karmanos Cancer Institute
  • Mayo Clinic Cancer Center
  • NYU Cancer Institute at New York University Medical Center
  • Memorial Sloan-Kettering Cancer Center
  • Abramson Cancer Center of the University of Pennsylvania
  • Brown University School of Medicine
  • University of Wisconsin Paul P. Carbone Comprehensive Cancer Center
  • Vince Lombardi Cancer Clinic at Aurora St. Luke's Medical Center

Outcomes

Primary Outcome Measures

Average difference in pre- and post-treatment worst pain score in a 24-hour period at week 8

Secondary Outcome Measures

Average difference in pre- and post-treatment worst pain score in a 24-hour period, average pain score, and pain relief score at 6, 12, and 24 months
Average amount of pain per patient over the observation period as represented by the area under the curve (AUC) constructed from weekly pain scores on a visual-analogue scale using a score of 0-10
Percentage of patients who are able to reduce analgesic medications

Full Information

First Posted
February 1, 2008
Last Updated
January 11, 2017
Sponsor
Mayo Clinic
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00608855
Brief Title
Percutaneous Cryoablation in Treating Patients With Painful Bone Metastases
Official Title
Percutaneous US and CT-guided Cryoablation of Painful Metastases Involving Bone: A Feasibility Study
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
November 2003 (undefined)
Primary Completion Date
February 2013 (Actual)
Study Completion Date
February 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mayo Clinic
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

Brief Summary
RATIONALE: Percutaneous cryoablation may help relieve pain caused by bone metastases. PURPOSE: This clinical trial is studying the side effects and how well percutaneous cryoablation works in treating patients with painful bone metastases.
Detailed Description
OBJECTIVES: To confirm the safety of percutaneous cryoablation in the palliative treatment of patients with painful bone metastases. To determine the benefits of cryoablation of painful bone metastases by assessing pain intensity using a standardized Cleeland Brief Pain Inventory (BPI) and quality of life using a standardized SF-8 both before and after treatment. To determine the secondary benefits of cryoablation of painful bone metastases by assessing change in analgesic use following therapy. To determine the level of anesthesia required for cryoablation with a baseline level of conscious sedation planned for each treatment. OUTLINE: This is a multicenter study. Patients undergo percutaneous cryoablation to one or two sites of metastatic disease using the Endocare Cryocare system. Patients with a good initial response to treatment (≥ 2 decrease in pain intensity rating on the Brief Pain Inventory) who develop recurrent pain at the same site or a new painful site ≥ 1 month after initial treatment may undergo one additional cryoablation treatment. Patients complete pain and quality of life questionnaires periodically. After completion of study treatment, patients are followed periodically for 2 years.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Cancer, Pain, Unspecified Adult Solid Tumor, Protocol Specific
Keywords
bone metastases, pain, unspecified adult solid tumor, protocol specific

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Masking
None (Open Label)
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Other
Intervention Name(s)
questionnaire administration
Intervention Type
Procedure
Intervention Name(s)
cryosurgery
Intervention Type
Procedure
Intervention Name(s)
pain therapy
Intervention Type
Procedure
Intervention Name(s)
quality-of-life assessment
Primary Outcome Measure Information:
Title
Average difference in pre- and post-treatment worst pain score in a 24-hour period at week 8
Secondary Outcome Measure Information:
Title
Average difference in pre- and post-treatment worst pain score in a 24-hour period, average pain score, and pain relief score at 6, 12, and 24 months
Title
Average amount of pain per patient over the observation period as represented by the area under the curve (AUC) constructed from weekly pain scores on a visual-analogue scale using a score of 0-10
Title
Percentage of patients who are able to reduce analgesic medications

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Matthew R. Callstrom, MD, PhD
Organizational Affiliation
Mayo Clinic
Official's Role
Study Chair
Facility Information:
Facility Name
Mayo Clinic - Jacksonville
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
Facility Name
University of Michigan Comprehensive Cancer Center
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109-0942
Country
United States
Facility Name
Barbara Ann Karmanos Cancer Institute
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201-1379
Country
United States
Facility Name
Mayo Clinic Cancer Center
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
NYU Cancer Institute at New York University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Memorial Sloan-Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Abramson Cancer Center of the University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104-4283
Country
United States
Facility Name
Brown University School of Medicine
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02912
Country
United States
Facility Name
University of Wisconsin Paul P. Carbone Comprehensive Cancer Center
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792-6164
Country
United States
Facility Name
Vince Lombardi Cancer Clinic at Aurora St. Luke's Medical Center
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53215
Country
United States

12. IPD Sharing Statement

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Percutaneous Cryoablation in Treating Patients With Painful Bone Metastases

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