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

NCT ID: NCT00006255

Last Updated: 2010-06-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 17 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2000-04-30
• Study Completion Date: 2005-03-31

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.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

radiofrequency ablation

Undergo thermal ablation by radiofrequency energy under magnetic resonance guidance.Thermal ablation continues until the entire tumor is treated.

Intervention Type: PROCEDURE

thermal ablation therapy

Undergo thermal ablation by radiofrequency energy under magnetic resonance guidance.Thermal ablation continues until the entire tumor is treated.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Case Comprehensive Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

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

Principal Investigators

John R. Haaga, MD

Role: STUDY_CHAIR

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

Locations

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

Cleveland, Ohio, United States

Countries

United States

Other Identifiers

P30CA043703

Identifier Type: NIH

Identifier Source: secondary_id

View Link

CWRU-2Y00

Identifier Type: -

Identifier Source: secondary_id

NCI-G00-1850

Identifier Type: -

Identifier Source: secondary_id

CWRU2Y00

Identifier Type: -

Identifier Source: org_study_id