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Home > "R" Clinical Trials Conditions > Radiofrequency Ablation in Treating Patients With Bone Metastases  Radiofrequency Ablation in Treating Patients With Bone Metastases
Radiofrequency Ablation in Treating Patients With Bone Metastases
For Condition: bone metastases,unspecified adult solid tumor, protocol specific,Pain
Status: Recruiting
Sponsor(s): American College of Radiology Imaging Network , National Cancer Institute (NCI)
Synopsis: RATIONALE: Radiofrequency ablation may be effective in decreasing pain from bone metastases. PURPOSE: Phase I/II trial to study the effectiveness of radiofrequency ablation in decreasing pain in patients who have bone metastases.
Details: OBJECTIVES: - Determine the side effects of radiofrequency ablation in patients with bone metastases. - Determine the effect of this regimen on pain in these patients. - Determine the effect of this regimen on mood in these patients. - Determine the effects of narcotic usage in patients treated with this regimen. - Determine the relationship between laboratory and imaging features of this treatment and the effects of the treatment in these patients. OUTLINE: This is a multicenter study. Patients undergo percutaneous CT-guided radiofrequency ablation directly to the metastatic lesion over approximately 12 minutes. Pain and mood are assessed at baseline, daily for 14 days after treatment, and at 1 and 3 months after treatment. Patients are followed at 1 week and then at 1 and 3 months. PROJECTED ACCRUAL: Approximately 75 patients will be accrued for this study within 12.5 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 21 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically or cytologically confirmed malignant disease with a bone lesion that appears to be metastatic disease by clinical and/or imaging techniques - Persistent intractable pain from a solitary site of bone metastases (greater than 5 on pain scale of 0-10) - Bone metastasis must be amenable to radiofrequency ablation using a percutaneous CT-guided approach - Bone metastasis must be no greater than 8 cm - No tumor mass in contact with hollow viscera - No primary musculoskeletal malignancies, lymphoma, or leukemia - No spinal metastases that do not have an intact cortex between the mass and the spinal canal and exiting nerve roots - No tumor involving weight-bearing long bone of lower extremity or impending fracture PATIENT CHARACTERISTICS: Age: - 21 and over Performance status: - Not specified Life expectancy: - Not specified Hematopoietic: - Platelet count at least 70,000/mm^3 - No uncontrolled coagulopathy or bleeding diathesis that cannot be corrected with fresh frozen plasma and platelets Hepatic: - Not specified Renal: - Not specified Cardiovascular: - No pacemaker PRIOR CONCURRENT THERAPY: Biologic therapy: - Not specified Chemotherapy: - At least 14 days since prior chemotherapy for metastatic disease - No concurrent systemic chemotherapy for metastatic disease during and for 14 days after study therapy Endocrine therapy: - Not specified Radiotherapy: - At least 30 days since prior radioisotopes for metastatic disease - No concurrent systemic radioisotopes for metastatic disease Surgery: - No surgical stabilization of tumor site with metallic hardware Other: - Prior aspirin, nonsteroidal anti-inflammatory medications, antiplatelet medications, or warfarin must be discontinued for an appropriate period of time prior to study based on the drug's half-life and known antiplatelet activity (e.g., 7 days for aspirin and 24 hours for ibuprofen) - At least 24 hours since prior low molecular weight heparin
Total Enrollment:
Location and Contact Information:
Overall Study Official:
DamianDupuy, Study Chair, Rhode Island Hospital
St. Elizabeth Cancer Center at St. Elizabeth Health Center - Youngstown *Recruiting*
Youngstown, Ohio, 44501
United States
Recruiting Richard Barr 330-480-3341
Rhode Island Hospital *Recruiting*
Providence, Rhode Island, 02903
United States
Recruiting Damian Dupuy 401-444-5184
University of California Davis Cancer Center *Recruiting*
Sacramento, California, 95817
United States
Recruiting John McGahan 916-734-6533
University of Texas - MD Anderson Cancer Center *Recruiting*
Houston, Texas, 77030-4009
United States
Recruiting Kamran Ahrar 713-745-0315
Siteman Cancer Center *Recruiting*
St. Louis, Missouri, 63110
United States
Recruiting Daniel Brown 314-362-2900
Abramson Cancer Center at University of Pennsylvania Medical Center *Recruiting*
Philadelphia, Pennsylvania, 19104-4283
United States
Recruiting S. Stavropoulos 215-349-6541
Beth Israel Deaconess Medical Center *Recruiting*
Boston, Massachusetts, 02215
United States
Recruiting Shraga Goldberg 617-754-2598
Comprehensive Cancer Center at Wake Forest University *Recruiting*
Winston Salem, North Carolina, 27157-1082
United States
Recruiting Frank Torti 336-716-7971
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia *Recruiting*
Philadelphia, Pennsylvania, 19107-5541
United States
Recruiting Adam Zoga 215-955-8890
Additional Information:
Study ID Numbers: CDR0000069012; ACRIN-6661
Study Start Date:
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00026247
Other Bone Metastases Studies:
1. DHA-Paclitaxel With or Without Gemcitabine in Treating Patients With Advanced Solid Tumors or Unresectable Pancreatic Cancer
2. PI-88 in Treating Patients With an Advanced Malignancy (Cancer) or Stage IV Melanoma
3. EF5 in Treating Patients With Solid Tumors
4. Geldanamycin Analogue in Treating Patients With Advanced Cancer
5. Vaccine Therapy in Treating Patients With Advanced Cancer
Related Studies:
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Radiofrequency Ablation in Treating Patients With Bone Metastases
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