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

February 26, 2013 updated by: Rupal Bhatt, MD, Beth Israel Deaconess Medical Center

Pilot Feasibility Protocol of RF Ablation of Treatment of Metastatic Lesions in Patients Undergoing Antiangiogenic Therapy for Stage IV Renal Cell Carcinoma

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To evaluate the safety, toxicity and feasibility of RFA for the treatment of metastatic lesion in patients undergoing antiangiogenic therapy.
Time Frame: 3 years
3 years

Secondary Outcome Measures

Outcome Measure
Time Frame
To evaluate the efficacy of RF ablation by measurement of diameter of ablation for treatment in this patient population.
Time Frame: 3 years
3 years
To evaluate relative efficacy of RFA in treatment of metastatic lesions showing sensitivity vs. resistance to anti-angiogenic therapy.
Time Frame: 3 years
3 years
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
3 years
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
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beth Israel Deaconess Medical Center

Investigators

  • Principal Investigator: Rupal Bhatt, MD, Beth Israel Deaconess Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2007

Primary Completion (Anticipated)

June 1, 2010

Study Registration Dates

First Submitted

January 15, 2008

First Submitted That Met QC Criteria

January 15, 2008

First Posted (Estimate)

January 25, 2008

Study Record Updates

Last Update Posted (Estimate)

February 27, 2013

Last Update Submitted That Met QC Criteria

February 26, 2013

Last Verified

February 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 06-287

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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