Percutaneous Cryoablation in Treating Patients With Painful Bone Metastases

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00608855
First received: February 1, 2008
Last updated: April 7, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention
Metastatic Cancer
Pain
Unspecified Adult Solid Tumor, Protocol Specific
Other: questionnaire administration
Procedure: cryosurgery
Procedure: pain therapy
Procedure: quality-of-life assessment

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Treatment
Official Title: Percutaneous US and CT-guided Cryoablation of Painful Metastases Involving Bone: A Feasibility Study

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Average difference in pre- and post-treatment worst pain score in a 24-hour period at week 8 [ Designated as safety issue: No ]

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 [ Designated as safety issue: No ]
  • 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 [ Designated as safety issue: No ]
  • Percentage of patients who are able to reduce analgesic medications [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: November 2003
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00608855

Locations
United States, Florida
Mayo Clinic - Jacksonville
Jacksonville, Florida, United States, 32224
United States, Michigan
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States, 48109-0942
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States, 48201-1379
United States, Minnesota
Mayo Clinic Cancer Center
Rochester, Minnesota, United States, 55905
United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
NYU Cancer Institute at New York University Medical Center
New York, New York, United States, 10016
United States, Pennsylvania
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104-4283
United States, Rhode Island
Brown University School of Medicine
Providence, Rhode Island, United States, 02912
United States, Wisconsin
University of Wisconsin Paul P. Carbone Comprehensive Cancer Center
Madison, Wisconsin, United States, 53792-6164
Vince Lombardi Cancer Clinic at Aurora St. Luke's Medical Center
Milwaukee, Wisconsin, United States, 53215
Sponsors and Collaborators
Mayo Clinic
Investigators
Study Chair: Matthew R. Callstrom, MD, PhD Mayo Clinic
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00608855     History of Changes
Other Study ID Numbers: MC03C3, MAYO-MC03C3
Study First Received: February 1, 2008
Last Updated: April 7, 2014
Health Authority: United States: Federal Government

Keywords provided by Mayo Clinic:
bone metastases
pain
unspecified adult solid tumor, protocol specific

Additional relevant MeSH terms:
Neoplasm Metastasis
Neoplasms
Neoplasms, Second Primary
Neoplastic Processes
Pathologic Processes

ClinicalTrials.gov processed this record on August 21, 2014