Percutaneous Cryoablation in Treating Patients With Painful Bone Metastases

NCT ID: NCT00608855

Last Updated: 2017-01-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-11-30
• Study Completion Date: 2013-02-28

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.

Conditions

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

Study Design

• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

questionnaire administration

Intervention Type: OTHER

cryosurgery

Intervention Type: PROCEDURE

pain therapy

Intervention Type: PROCEDURE

quality-of-life assessment

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 120 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Mayo Clinic

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Matthew R. Callstrom, MD, PhD

Role: STUDY_CHAIR

Mayo Clinic

Locations

Mayo Clinic - Jacksonville

Jacksonville, Florida, United States

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, United States

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, United States

Mayo Clinic Cancer Center

Rochester, Minnesota, United States

NYU Cancer Institute at New York University Medical Center

New York, New York, United States

Memorial Sloan-Kettering Cancer Center

New York, New York, United States

Abramson Cancer Center of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

Brown University School of Medicine

Providence, Rhode Island, United States

University of Wisconsin Paul P. Carbone Comprehensive Cancer Center

Madison, Wisconsin, United States

Vince Lombardi Cancer Clinic at Aurora St. Luke's Medical Center

Milwaukee, Wisconsin, United States

Countries

United States

Other Identifiers

MAYO-MC03C3

Identifier Type: -

Identifier Source: secondary_id

MC03C3

Identifier Type: -

Identifier Source: org_study_id