Magnetic Resonance Imaging-guided Thermal Radiofrequencey Ablation of Primary Renal Cell Carcinoma, Hepatic Metastasis, and Other Sites of Solid Organ Tumor and Metastases
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Purpose
RATIONALE: Radiofrequency ablation uses high-frequency electric current to heat and kill tumor cells. Magnetic resonance imaging-guided radiofrequency ablation may an effective treatment for primary kidney cancer, liver metastases, or other solid tumors.
PURPOSE: Phase II trial to study the effectiveness of magnetic-resonance-guided radiofrequency ablation in treating patients who have primary kidney cancer, liver metastases, or other solid tumors.
| Condition | Intervention | Phase |
|---|---|---|
|
Kidney Cancer Metastatic Cancer Unspecified Adult Solid Tumor, Protocol Specific |
Procedure: radiofrequency ablation Procedure: thermal ablation therapy |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase II Study of Magnetic Resonance Guided and Monitored Interstitial Thermal Radiofrequency Ablation of Primary Renal Cell Carcinoma, Hepatic Metastasis, and Other Sites of Solid Organ Tumor and Metastases |
- Determine whether magnetic resonance image monitoring during radiofrequency interstitial thermal ablation can accurately predict complete destruction of focal tumor along with an adequate margin of normal tissue. [ Time Frame: Patients are followed at 2 weeks and at 3, 6, 9, and 12 months. ] [ Designated as safety issue: No ]
| Enrollment: | 17 |
| Study Start Date: | April 2000 |
| Study Completion Date: | March 2005 |
| Primary Completion Date: | March 2005 (Final data collection date for primary outcome measure) |
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Procedure: radiofrequency ablation
OBJECTIVES:
- Determine whether magnetic resonance image monitoring during radiofrequency interstitial thermal ablation can accurately predict complete destruction of focal tumor along with an adequate margin of normal tissue, as demonstrated by absence of growth on subsequent imaging studies for a 1-year period, in patients with primary renal cell carcinoma, hepatic metastases, or other solid tumors.
OUTLINE: Patients are stratified according to disease (localized hepatic metastases vs primary renal neoplasms vs solid tumors in other sites).
Patients undergo thermal ablation by radiofrequency energy under magnetic resonance guidance. Thermal ablation continues until the entire tumor is treated. Treatment ceases when the entire lesion has undergone necrosis or the zone of necrosis or significant heat deposition approaches vital neurovascular structures.
Patients are followed at 2 weeks and at 3, 6, 9, and 12 months.
PROJECTED ACCRUAL: A total of 28-39 patients will be accrued for this study within 22-36 months.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of primary renal cell carcinoma, hepatic metastases, or other solid tumor meeting the following criteria:
- Not amenable to curative or substantial palliative therapy OR
- Failed chemotherapy or biological response modifier therapy OR
- Unlikely to benefit from conventional chemotherapy
No more than 5 measurable metastatic masses in the liver
- No greater than 5 cm in diameter
- Other tumor sites allowed if location and size amenable to ablation therapy
- Measurable disease
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- ECOG 0-2
Life expectancy:
- More than 4 months
Hematopoietic:
- Granulocyte count at least 1,000/mm^3
- Hemoglobin at least 8.0 g/dL
- Platelet count at least 100,000/mm^3
- No untreated bleeding diathesis
Hepatic:
- PT no greater than 13.5 seconds
- PT/PTT normal if prior warfarin or heparin use
Renal:
- Not specified
Cardiovascular:
- No implanted pacemaker, incompatible aneurysm clip, or other device that would preclude magnetic resonance imaging
- No myocardial infarction within the past 6 weeks
- No unstable angina
Other:
- Not pregnant or nursing
- No serious active infection
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- See Disease Characteristics
- At least 28 days since prior biological response modifier therapy
Chemotherapy:
- See Disease Characteristics
- At least 28 days since prior chemotherapy
Endocrine therapy:
- Not specified
Radiotherapy:
- No prior radiotherapy to study lesion
Surgery:
- Not specified
Other:
- At least 7 days since prior nonsteroidal antiinflammatory drugs or aspirin
- At least 1 hour since prior heparin
- No concurrent warfarin
- No concurrent investigational drugs
Contacts and Locations| United States, Ohio | |
| Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center | |
| Cleveland, Ohio, United States, 44106-5056 | |
| Study Chair: | John R. Haaga, MD | Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center |
More Information
Additional Information:
No publications provided
| Responsible Party: | John R. Haaga, MD, Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00006255 History of Changes |
| Other Study ID Numbers: | CWRU2Y00, P30CA043703, CWRU-2Y00, NCI-G00-1850 |
| Study First Received: | September 11, 2000 |
| Last Updated: | June 9, 2010 |
| Health Authority: | United States: Federal Government |
Keywords provided by Case Comprehensive Cancer Center:
|
stage III renal cell cancer stage IV renal cell cancer recurrent renal cell cancer unspecified adult solid tumor, protocol specific liver metastases |
Additional relevant MeSH terms:
|
Carcinoma Carcinoma, Renal Cell Kidney Neoplasms Neoplasm Metastasis Neoplasms Neoplasms, Second Primary Liver Neoplasms Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Adenocarcinoma |
Urologic Neoplasms Urogenital Neoplasms Neoplasms by Site Kidney Diseases Urologic Diseases Neoplastic Processes Pathologic Processes Digestive System Neoplasms Digestive System Diseases Liver Diseases |
ClinicalTrials.gov processed this record on May 21, 2013