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

June 24, 2008
June 1, 2011
January 2003
October 2008   (final data collection date for primary outcome measure)
To determine the safety of RFA in patients with childhood acquired tumors [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00705497 on ClinicalTrials.gov Archive Site
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Radiofrequency Ablation of Tumors
Radiofrequency Ablation of Tumors (RFA) A Phase I Study

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.

Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Primary Tumors
  • Metastatic Tumors
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.
Experimental: 1
Intervention: Procedure: Radiofrequency Tumor Ablation
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
31
October 2008
October 2008   (final data collection date for primary outcome measure)

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
Both
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No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00705497
RFA
No
Matthew Krasin MD, St. Jude Children's Research Hospital
St. Jude Children's Research Hospital
Not Provided
Principal Investigator: Matthew Krasin, MD St. Jude Children's Research Hospital
St. Jude Children's Research Hospital
June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP