Radiofrequency Ablation of Tumors
Primary Purpose
Primary Tumors, Metastatic Tumors
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Radiofrequency Tumor Ablation
Sponsored by
About this trial
This is an interventional treatment trial for Primary Tumors focused on measuring Radiofrequency tumor ablation, RFA
Eligibility 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
Sites / Locations
- St. Jude Children's Research Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
Outcomes
Primary Outcome Measures
To determine the safety of RFA in patients with childhood acquired tumors
Secondary Outcome Measures
Full Information
NCT ID
NCT00705497
First Posted
June 24, 2008
Last Updated
April 24, 2017
Sponsor
St. Jude Children's Research Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00705497
Brief Title
Radiofrequency Ablation of Tumors
Official Title
Radiofrequency Ablation of Tumors (RFA) A Phase I Study
Study Type
Interventional
2. Study Status
Record Verification Date
June 2011
Overall Recruitment Status
Completed
Study Start Date
January 2003 (undefined)
Primary Completion Date
October 2008 (Actual)
Study Completion Date
October 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
St. Jude Children's Research Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Tumors, Metastatic Tumors
Keywords
Radiofrequency tumor ablation, RFA
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
31 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Radiofrequency Tumor Ablation
Intervention Description
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.
Primary Outcome Measure Information:
Title
To determine the safety of RFA in patients with childhood acquired tumors
Time Frame
5 years
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Matthew Krasin, MD
Organizational Affiliation
St. Jude Children's Research Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Jude Children's Research Hospital
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38105
Country
United States
12. IPD Sharing Statement
Links:
URL
http://www.stjude.org
Description
Related Info
Learn more about this trial
Radiofrequency Ablation of Tumors
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