Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

Magnetic-Resonance-Guided Radiofrequency Ablation in Treating Patients With Primary Kidney Cancer, Liver Metastases, or Other Solid Tumors

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II Treatment Closed 18 and over NCI CWRU-2Y00 NCI-G00-1850, NCT00006255

Objectives

1. 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.

Entry 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

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

Patient Characteristics:

Age:

• 18 and over

Performance status:

• ECOG 0-2

Life expectancy:

• More than 4 months

Hematopoietic:

• Granulocyte count at least 1,000/mm³
• Hemoglobin at least 8.0 g/dL
• Platelet count at least 100,000/mm³
• 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

Expected Enrollment

A total of 28-39 patients will be accrued for this study within 22-36 months.

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.

Trial Contact Information

Trial Lead Organizations

Ireland Cancer Center at University Hospitals/Case Medical Center

John Haaga, MD, Protocol chair		Ph: 216-844-3858; 800-641-2422 Email: haaga@uhrad.com

Registry Information
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
Trial Start Date		2000-04-17
Registered in ClinicalTrials.gov		NCT00006255
Date Submitted to PDQ		2000-08-01
Information Last Verified		2005-03-28
NCI Grant/Contract Number		P30-CA43703

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