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Status:

COMPLETED

Percutaneous Cryoablation in Treating Patients With Painful Bone Metastases

Lead Sponsor:

Mayo Clinic

Collaborating Sponsors:

National Cancer Institute (NCI)

Conditions:

Metastatic Cancer

Pain

Eligibility:

All Genders

18-120 years

Phase:

NA

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 treatin...

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 meta...

Eligibility Criteria

Inclusion

  • 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

Exclusion

    Key Trial Info

    Start Date :

    November 1 2003

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ESTIMATED

    End Date :

    February 1 2013

    Estimated Enrollment :

    60 Patients enrolled

    Trial Details

    Trial ID

    NCT00608855

    Start Date

    November 1 2003

    End Date

    February 1 2013

    Last Update

    January 12 2017

    Active Locations (10)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 3 (10 locations)

    1

    Mayo Clinic - Jacksonville

    Jacksonville, Florida, United States, 32224

    2

    University of Michigan Comprehensive Cancer Center

    Ann Arbor, Michigan, United States, 48109-0942

    3

    Barbara Ann Karmanos Cancer Institute

    Detroit, Michigan, United States, 48201-1379

    4

    Mayo Clinic Cancer Center

    Rochester, Minnesota, United States, 55905