Background: This prospective study was designed to be the first to evaluate the toxicity of
radiofrequency ablation (RFA) in patients with recurrent pediatric solid tumors.
Methods: From 2003 through 2006, we conducted a phase I, IRB-approved study of RFA for
recurrent solid tumors. A multidisciplinary cancer management team selected appropriate
candidates for the study. Imaging-guided RFA was performed percutaneously. Response was
assessed at 3 months. Repeat RFA was performed for some incompletely ablated or new lesions.
- Any age
- Previously diagnosed malignancy (including aggressive fibromatosis) originally
acquired during childhood (<21 years-of-age)
- Patients who have undergone previous RFA may be enrolled again (different disease
site) or receive subsequent ablation (same disease site) as long as the eligibility
criteria are met at the time of re-enrollment, or a second ablation on study.
- The subject is medically appropriate for the study as determined by a consensus of
professionals at multidisciplinary tumor conference prior to enrollment. This
discussion will be documented in the chart of the potential subject to be recruited
for this study.
- Histopathological material is available prior to the RF ablation except in patients
with obvious tumor recurrence.
- No Pacemakers or Automatic Implantable Cardioverter/Defibrillators (AICDs)
- No tissue burns anticipated from implanted metal
- Normal renal function (Creatinine < 2mg/dL)
- Absolute neutrophil count (ANC) > 1000/cu.mm.
- No uncorrectable coagulopathy (INR>1.5, PTT and PT > 1.5 x the upper limit of
- No uncorrectable thrombocytopenia (platelet count < 50,000/mm3)
- Life expectancy over 30 days
- RF ablation targets in the liver, lung or musculoskeletal system that meet the
- Intrahepatic metastases not amenable to other therapy
- Primary hepatic tumor if RF ablation of a portion of the tumor can lead to primary
tumor resection rather than hepatic transplantation
- Single primary or multiple tumors in the liver
- At least one over 0.5 cm in diameter
- Edge of lesion not contiguous with main hepatic or common biliary duct.
- Local or regional recurrence of primary bone or soft tissue tumor not amenable to
resection or radiotherapy
- Osseous, soft tissue or lymph node metastases not amenable to resection or
- Head, neck, spine, extremity, chest wall, flank, abdominal wall, or pelvic bone or
girdle lesions are treatable under this protocol
- RFA target < 50% of axial area in weight bearing bone unless reinforced with internal
fixation (bone cement infusion) or in non-ambulatory patient.
- No supplemental oxygenation is required.
- Metastatic solid tumor that has recurred or progressed after primary thoracotomy or
thoracoscopic removal that is not amenable to radiotherapy, surgery or chemotherapy
- In the investigator's opinion, no supplemental oxygen will likely be required at rest
for more than 30 days after RF ablation.
- Tumor burden < 20% of lung volume