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

Sponsor:	Case Comprehensive Cancer Center
Collaborator:	National Cancer Institute (NCI)
Information provided by:	Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier:	NCT00006255

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.

Condition	Intervention	Phase
Kidney Cancer Metastatic Cancer Unspecified Adult Solid Tumor, Protocol Specific	Procedure: radiofrequency ablation Procedure: thermal ablation therapy	Phase II

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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Kidney Cancer MRI Scans

U.S. FDA Resources

Further study details as provided by Case Comprehensive Cancer Center:

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. [ Time Frame: Patients are followed at 2 weeks and at 3, 6, 9, and 12 months. ] [ Designated as safety issue: No ]

Enrollment:	17
Study Start Date:	April 2000
Study Completion Date:	March 2005
Primary Completion Date:	March 2005 (Final data collection date for primary outcome measure)

Intervention Details:

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

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00006255

Locations

United States, Ohio
Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44106-5056

Sponsors and Collaborators

Case Comprehensive Cancer Center

National Cancer Institute (NCI)

Investigators

Study Chair:

John R. Haaga, MD

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

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	John R. Haaga, MD, Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier:	NCT00006255 History of Changes
Other Study ID Numbers:	CWRU2Y00, P30CA043703, CWRU-2Y00, NCI-G00-1850
Study First Received:	September 11, 2000
Last Updated:	June 9, 2010
Health Authority:	United States: Federal Government

Keywords provided by Case Comprehensive Cancer Center:

stage III renal cell cancer
stage IV renal cell cancer
recurrent renal cell cancer
unspecified adult solid tumor, protocol specific
liver metastases

Additional relevant MeSH terms:

Carcinoma
Carcinoma, Renal Cell
Kidney Neoplasms
Neoplasm Metastasis
Neoplasms
Neoplasms, Second Primary
Liver Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Adenocarcinoma

Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Neoplastic Processes
Pathologic Processes
Digestive System Neoplasms
Digestive System Diseases
Liver Diseases

ClinicalTrials.gov processed this record on February 12, 2012