Magnetic Resonance Imaging-guided Thermal Radiofrequencey Ablation of Primary Renal Cell Carcinoma, Hepatic Metastasis, and Other Sites of Solid Organ Tumor and Metastases

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Kidney Cancer, Metastatic Cancer, Unspecified Adult Solid Tumor, Protocol Specific

Intervention / Treatment
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* Procedure: radiofrequency ablation
* Procedure: thermal ablation therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: radiofrequency ablation|Undergo thermal ablation by radiofrequency energy under magnetic resonance guidance.Thermal ablation continues until the entire tumor is treated.|
|Procedure: thermal ablation therapy|Undergo thermal ablation by radiofrequency energy under magnetic resonance guidance.Thermal ablation continues until the entire tumor is treated.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |  | Patients are followed at 2 weeks and at 3, 6, 9, and 12 months. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stage III renal cell cancer, stage IV renal cell cancer, recurrent renal cell cancer, unspecified adult solid tumor, protocol specific, liver metastases