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

Unspecified Adult Solid Tumor, Protocol Specific Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00006255
• Other study ID #: CWRU2Y00
• Secondary ID: P30CA043703CWRU-
• Status: Completed
• Phase: Phase 2
• First received: September 11, 2000
• Last updated: June 9, 2010
• Start date: April 2000
• Est. completion date: March 2005

Study information

• Verified date: June 2010
• Source: Case Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: March 2005
• Est. primary completion date: March 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Renal Cell
• Kidney Cancer
• Metastatic Cancer
• Neoplasm Metastasis
• Unspecified Adult Solid Tumor, Protocol Specific

Intervention

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

Locations

Country	Name	City	State
United States	Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center	Cleveland	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Case Comprehensive Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No