RF Ablation of Treatment of Metastatic Lesions in Patients Undergoing Antiangiogenic Therapy for Stage IV Renal Cell Carcinoma - Full Text View

Sponsored by:	Beth Israel Deaconess Medical Center
Information provided by:	Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:	NCT00601120

Purpose

The purpose of this study is to look at the effects of a procedure called radiofrequency ablation on kidney tumors from patients who are undergoing antiangiogenic treatment. Antiangiogenic treatment is a type of treatment that inhibits formation of new blood vessels that are required for tumor growth. Radiofrequency ablation (RF ablation) involves inserting a needle into tumor tissue and administering heat to the tumor tissue that is sufficient to kill the tumor cells.

Condition	Intervention
Renal Cell Carcinoma	Procedure: Radiofrequency Ablation

MedlinePlus related topics: Cancer

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title:	Pilot Feasibility Protocol of RF Ablation of Treatment of Metastatic Lesions in Patients Undergoing Antiangiogenic Therapy for Stage IV Renal Cell Carcinoma

Further study details as provided by Dana-Farber Cancer Institute:

Primary Outcome Measures:

To evaluate the safety, toxicity and feasibility of RFA for the treatment of metastatic lesion in patients undergoing antiangiogenic therapy. [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

To evaluate the efficacy of RF ablation by measurement of diameter of ablation for treatment in this patient population. [ Time Frame: 3 years ] [ Designated as safety issue: No ]
To evaluate relative efficacy of RFA in treatment of metastatic lesions showing sensitivity vs. resistance to anti-angiogenic therapy. [ Time Frame: 3 years ] [ Designated as safety issue: No ]
To examine the mechanism of resistance to antiangiogenic therapy by examining the pathologic findings in sensitive and resistant metastatic lesions in patients with RCC treated with sorafenib and sunitinib. [ Time Frame: 3 years ] [ Designated as safety issue: No ]
To study the relationship of peripheral blood angiogenic markers and vascular imaging to molecular changes within the tumor in sensitive and resistant metastatic lesions. [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Estimated Enrollment:	30
Study Start Date:	June 2007
Estimated Primary Completion Date:	June 2010 (Final data collection date for primary outcome measure)

Intervention Details:

Needles are inserted into the tumor(s) under guidance by a CT scan or ultrasound. The electrodes in the needles will be heated up to 202 degrees Fahrenheit and will remain heated for up to 12 minutes.

Detailed Description:

Participants will undergo a RF ablation procedure of one or more of their tumors that have not gone away while they have been undergoing antiangiogenic treatment. The RF ablation procedure will be performed in the operating room at one of the Dana-Farber/Harvard Cancer Center hospitals and will be performed under general anesthesia.
Blood will also be drawn 2-4 weeks before the procedure, at the time of teh procedure and 2-4 weeks after the procedure.
The RF ablation procedure will be performed at specified times in relation to the participants antiangiogenic treatment (sorafenib or sunitinib): a) If the participant is taking sorafenib, they will be asked to stop taking it 2-5 days prior to the RF ablation procedure; b) if the participant is taking sunitinib, they will be asked to stop taking it 4-7 days prior to the RF ablation procedure.
Participants will have an MRI or a CT scan of their tumor(s) within 2-4 weeks of the procedure and 2-4 weeks after the procedure. The MRI or CT will scan the tumor(s) to determine how much blood flow is going to them.
At the time of RF ablation, participants will have a biopsy of their tumor(s) and will receive a CT scan in the area the ablation was performed after the procedure to assess for any bleeding. They will also be monitored for 4 hours after the RF ablation procedure.

Eligibility

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

Criteria

Inclusion Criteria:

Patients who are on antiangiogenic therapy for a minimum of 4 weeks and have isolated metastatic lesions showing either persistence or resistance to therapy that might benefit from local therapy such as RF ablation.
Male or female patients 18 years of age or older
Clinical, radiographic, or pathologic diagnosis of clear cell RCC
Ongoing treatment with sorafenib or sunitinib, off clinical trials
Acceptable risk for general anesthesia in the judgement of the study investigator and by the department of anesthesiology upon preoperative testing.
At least one lesion that has not completely resolved while on antiangiogenic therapy
Candidate lesions of 1cm or greater in diameter
Safe access to the tumor for a needle placed under ultrasound guidance
ECOG Performance Status of 0 or 1
Adequate bone marrow, and renal as assessed by the laboratory requirements outlined in the protocol

Exclusion Criteria:

History of bleeding diathesis or unexpected surgical bleeding
Patients currently on anticoagulation
Medical contraindication to MR imaging (pacemaker, metal debris in eye, etc.)
Prior RF to the index tumor
Pregnant or lactating

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00601120

Locations

United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02115

Sponsors and Collaborators

Beth Israel Deaconess Medical Center

Investigators

Principal Investigator:

Rupal Bhatt, MD

Beth Israel Deaconess Medical Center

More Information

Responsible Party:	Beth Israel Deaconess Medical Center ( Rupal Bhatt, MD )
Study ID Numbers:	06-287
Study First Received:	January 15, 2008
Last Updated:	December 11, 2008
ClinicalTrials.gov Identifier:	NCT00601120
Health Authority:	United States: Institutional Review Board

Keywords provided by Dana-Farber Cancer Institute:

antiangiogenic therapy
RF ablation

Study placed in the following topic categories:

Urologic Diseases
Kidney Neoplasms
Carcinoma, Renal Cell
Urogenital Neoplasms
Renal cancer
Kidney Diseases

Kidney cancer
Urologic Neoplasms
Adenocarcinoma
Urinary tract neoplasm
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on January 16, 2009