Radiofrequency Ablation of Tumors

This study has been completed.
Sponsor:
Information provided by:
St. Jude Children's Research Hospital
ClinicalTrials.gov Identifier:
NCT00705497
First received: June 24, 2008
Last updated: June 1, 2011
Last verified: June 2011
  Purpose

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.


Condition Intervention Phase
Primary Tumors
Metastatic Tumors
Procedure: Radiofrequency Tumor Ablation
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Radiofrequency Ablation of Tumors (RFA) A Phase I Study

Resource links provided by NLM:


Further study details as provided by St. Jude Children's Research Hospital:

Primary Outcome Measures:
  • To determine the safety of RFA in patients with childhood acquired tumors [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]

Enrollment: 31
Study Start Date: January 2003
Study Completion Date: October 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Procedure: Radiofrequency Tumor Ablation
Radiofrequency tumor ablation (RFA) is an imaging guided percutaneous or intra-operative procedure that uses a probe on the end of a sharp needle that is inserted directly into the tumor. The tumor is ablated by heating the probe (using electrical current alternating at radio frequency) which raises the temperature of the tumor potentially causing irreversible cell death.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

General

  • 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 normal)
  • 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 radiotherapy.
  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00705497

Locations
United States, Tennessee
St. Jude Children's Research Hospital
Memphis, Tennessee, United States, 38105
Sponsors and Collaborators
St. Jude Children's Research Hospital
Investigators
Principal Investigator: Matthew Krasin, MD St. Jude Children's Research Hospital
  More Information

Additional Information:
No publications provided

Responsible Party: Matthew Krasin MD, St. Jude Children's Research Hospital
ClinicalTrials.gov Identifier: NCT00705497     History of Changes
Other Study ID Numbers: RFA
Study First Received: June 24, 2008
Last Updated: June 1, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by St. Jude Children's Research Hospital:
Radiofrequency tumor ablation
RFA

Additional relevant MeSH terms:
Neoplasm Metastasis
Neoplastic Processes
Neoplasms
Pathologic Processes

ClinicalTrials.gov processed this record on April 17, 2014