RATIONALE: Radiofrequency ablation uses high-frequency electric current to kill tumor cells and may help to relieve pain caused by bone metastases.

PURPOSE: Phase II trial to study the effectiveness of radiofrequency ablation in relieving pain in patients who have bone metastases.

Condition	Treatment or Intervention	Phase
bone metastases Pain	Procedure: hyperthermia  Procedure: pain therapy  Procedure: radiofrequency interstitial ablation  Procedure: supportive care/therapy	Phase II

Further Study Details: 

OBJECTIVES:

• Determine the efficacy of radiofrequency ablation, in terms of pain relief at 4 weeks, in patients with painful bone metastases.
• Determine the safety of this regimen in these patients.
• Compare the change in pain interference with daily life and analgesic use at 4 weeks vs baseline in patients treated with this regimen.
• Determine the time to recurrence of worst pain in patients treated with this regimen.

OUTLINE: This is a multicenter study.

Patients receive radiofrequency ablation (RFA) to targeted tumor(s) on day 0 (multiple tumors may receive ablation in multiple sessions). Patients who achieve a reduction in worst pain of at least 2 points within 4-8 weeks but experience recurring pain at the RFA site or are diagnosed with a new painful lesion within 4-24 weeks receive 1 additional treatment to the recurring or new site.

Pain (using the Brief Pain Inventory scale of 0-10), analgesic use, and quality of life are assessed at baseline, on day 1, weekly for 4 weeks, and then every 2 weeks for 20 weeks.

Patients are followed for 6 months beyond the last RFA treatment.

PROJECTED ACCRUAL: A maximum of 50 patients will be accrued for this study.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed bone metastases
• Pain refractory to non-opioid analgesic medication and radiotherapy OR
• Patient is considered a poor candidate for opioid analgesics or radiotherapy
• Initial worst pain score within the past 24 hours at least 4 on a scale of 0-10
• Tumors deemed accessible for radiofrequency ablation
• No evidence of impending fracture in weight-bearing bones (more than 50% loss of cortical bone)
• Tumors must be more than 1 cm from critical structures including:
• Spinal cord, brain, or other critical nerve structures
• Large abdominal vessel (e.g., aorta or inferior vena cava)
• Bowel or bladder

PATIENT CHARACTERISTICS: Age:

• 18 and over

Performance status:

• Not specified

Life expectancy:

• More than 2 months

Hematopoietic:

• Platelet count at least 75,000/mm3

Hepatic:

• INR less than 1.5

Renal:

• Not specified

Other:

• Not pregnant or nursing
• Negative pregnancy test

PRIOR CONCURRENT THERAPY: Biologic therapy:

• Not specified

Chemotherapy:

• At least 3 weeks since prior chemotherapy

Endocrine therapy:

• Not specified

Radiotherapy:

• At least 3 weeks since prior radiotherapy

Surgery:

• Not specified

Other:

• At least 3 days since prior aspirin, ibuprofen, or other nonsteroidal anti-inflammatory drugs
• No concurrent anticoagulants

Illinois
      Northwestern Memorial Hospital, Chicago,  Illinois,  60611,  United States
Maryland
      Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore,  Maryland,  21287,  United States
Massachusetts
      Massachusetts General Hospital Cancer Center, Boston,  Massachusetts,  02114,  United States
Minnesota
      Mayo Clinic Cancer Center, Rochester,  Minnesota,  55905,  United States
Texas
      University of Texas - MD Anderson Cancer Center, Houston,  Texas,  77030-4009,  United States
Wisconsin
      St. Luke's Medical Center, Milwaukee,  Wisconsin,  53215,  United States

Study chairs or principal investigators

J. William Charboneau, MD,  Study Chair,  Mayo Clinic Cancer Center   

Study ID Numbers:  CDR0000069180; RITA-201-00; MAYO-IRB-O-1223-00; MDA-ID-01534; RITA-IDE-G000177
Record last reviewed:  February 2003
Last Updated:  October 13, 2004
Record first received:  January 4, 2002
ClinicalTrials.gov Identifier:  NCT00029029
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08