Percutaneous Cryoablation in Treating Patients With Painful Bone Metastases - Full Text View

Sponsors and Collaborators:	Mayo Clinic National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00608855

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	Procedure: cryosurgery Procedure: pain therapy Procedure: quality-of-life assessment Procedure: questionnaire administration

MedlinePlus related topics: Cancer

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label
Official Title:	Percutaneous US and CT-Guided Cryoablation of Painful Metastases Involving Bone: A Feasibility Study

Further study details as provided by National Cancer Institute (NCI):

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 2010 (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

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

Locations

United States, Florida
Mayo Clinic - Jacksonville	Recruiting
Jacksonville, Florida, United States, 32224
Contact: Clinical Trials Office - All Mayo Clinic Locations 507-538-7623
United States, Michigan
Barbara Ann Karmanos Cancer Institute	Recruiting
Detroit, Michigan, United States, 48201-1379
Contact: Clinical Trials Office - Barbara Ann Karmanos Cancer Institute 313-576-9363
University of Michigan Comprehensive Cancer Center	Recruiting
Ann Arbor, Michigan, United States, 48109-0942
Contact: Clinical Trials Office - University of Michigan Comprehensive 800-865-1125
United States, Minnesota
Mayo Clinic Cancer Center	Recruiting
Rochester, Minnesota, United States, 55905
Contact: Clinical Trials Office - All Mayo Clinic Locations 507-538-7623
United States, New York
Memorial Sloan-Kettering Cancer Center	Recruiting
New York, New York, United States, 10021
Contact: Steven Solomon, MD 212-639-2000
NYU Cancer Institute at New York University Medical Center	Recruiting
New York, New York, United States, 10016
Contact: Leon Rybak, MD 212-263-6485
United States, Pennsylvania
Abramson Cancer Center of the University of Pennsylvania	Recruiting
Philadelphia, Pennsylvania, United States, 19104-4283
Contact: Clinical Trials Office - Abramson Cancer Center of the Univers 800-474-9892
United States, Rhode Island
Brown University School of Medicine	Recruiting
Providence, Rhode Island, United States, 02912
Contact: Damian E. Dupuy, MD 401-863-3330
United States, Wisconsin
University of Wisconsin Paul P. Carbone Comprehensive Cancer Center	Recruiting
Madison, Wisconsin, United States, 53792-6164
Contact: Clinical Trials Office - University of Wisconsin Paul P. Carbo 608-262-5223
Vince Lombardi Cancer Clinic at Aurora St. Luke's Medical Center	Recruiting
Milwaukee, Wisconsin, United States, 53215
Contact: Clinical Trials Office - Vince Lombardi Cancer Clinic 414-649-5717

Sponsors and Collaborators

Mayo Clinic

National Cancer Institute (NCI)

Investigators

Study Chair:	Matthew R. Callstrom, MD, PhD	Mayo Clinic
Investigator:	Thomas D. Atwell, MD	Mayo Clinic
Investigator:	Matthew P. Goetz, MD	Mayo Clinic
Investigator:	J. William Charboneau, MD	Mayo Clinic
Investigator:	Joseph Rubin, MD	Mayo Clinic
Investigator:	Michael A. Farrell	Mayo Clinic
Investigator:	Timothy P. Maus, MD	Mayo Clinic
Investigator:	Timothy J. Welch, MD	Mayo Clinic
Investigator:	Douglas A. Nichols, MD	Mayo Clinic
Investigator:	Yolanda I. Garces, MD	Mayo Clinic

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Study ID Numbers:	CDR0000581162, MAYO-MC03C3
Study First Received:	February 1, 2008
Last Updated:	December 31, 2008
ClinicalTrials.gov Identifier:	NCT00608855
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

bone metastases
pain
unspecified adult solid tumor, protocol specific

Study placed in the following topic categories:

Neoplasm Metastasis
Pain

Additional relevant MeSH terms:

Neoplasms
Neoplastic Processes
Pathologic Processes

ClinicalTrials.gov processed this record on January 16, 2009