Expired Study
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Cleveland, Ohio 44106


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.


Study summary:

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.


Criteria:

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


NCT ID:

NCT00006255


Primary Contact:

Study Chair
John R. Haaga, MD
Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center


Backup Contact:

N/A


Location Contact:

Cleveland, Ohio 44106
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: September 20, 2017

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