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Radiofrequency Ablation of Tumors (RFA) A Phase I Study

Phase 1
Not Enrolling
Primary Tumors, Metastatic Tumors

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Trial Information

Radiofrequency Ablation of Tumors (RFA) A Phase I Study

Inclusion Criteria:


- 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/

- 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
following criteria:

Hepatic lesions

- 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.

Musculoskeletal lesions

- 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.

Lung lesions

- 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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To determine the safety of RFA in patients with childhood acquired tumors

Outcome Time Frame:

5 years

Safety Issue:


Principal Investigator

Matthew Krasin, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

St. Jude Children's Research Hospital


United States: Institutional Review Board

Study ID:




Start Date:

January 2003

Completion Date:

October 2008

Related Keywords:

  • Primary Tumors
  • Metastatic Tumors
  • Radiofrequency tumor ablation
  • RFA
  • Neoplasm Metastasis



St. Jude Children's Research HospitalMemphis, Tennessee  38105-2794