A Phase I/II Study of Percutaneous Radiofrequency Ablation of Bone Metastases Using CT Guidance

Inclusion 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