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

Primary Purpose

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

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
radiofrequency ablation
thermal ablation therapy
Sponsored by
Case Comprehensive Cancer Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Kidney Cancer focused on measuring stage III renal cell cancer, stage IV renal cell cancer, recurrent renal cell cancer, unspecified adult solid tumor, protocol specific, liver metastases

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
September 11, 2000
Last Updated
June 9, 2010
Sponsor
Case Comprehensive Cancer Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00006255
Brief Title
Magnetic Resonance Imaging-guided Thermal Radiofrequencey Ablation of Primary Renal Cell Carcinoma, Hepatic Metastasis, and Other Sites of Solid Organ Tumor and Metastases
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2010
Overall Recruitment Status
Completed
Study Start Date
April 2000 (undefined)
Primary Completion Date
March 2005 (Actual)
Study Completion Date
March 2005 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Case Comprehensive Cancer Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Cancer, Metastatic Cancer, Unspecified Adult Solid Tumor, Protocol Specific
Keywords
stage III renal cell cancer, stage IV renal cell cancer, recurrent renal cell cancer, unspecified adult solid tumor, protocol specific, liver metastases

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
17 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
radiofrequency ablation
Intervention Description
Undergo thermal ablation by radiofrequency energy under magnetic resonance guidance.Thermal ablation continues until the entire tumor is treated.
Intervention Type
Procedure
Intervention Name(s)
thermal ablation therapy
Intervention Description
Undergo thermal ablation by radiofrequency energy under magnetic resonance guidance.Thermal ablation continues until the entire tumor is treated.
Primary Outcome Measure Information:
Title
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John R. Haaga, MD
Organizational Affiliation
Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106-5056
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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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