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


N/A
18 Years
N/A
Not Enrolling
Both
Renal Cell Carcinoma

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Trial Information

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


- 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.


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To evaluate the safety, toxicity and feasibility of RFA for the treatment of metastatic lesion in patients undergoing antiangiogenic therapy.

Outcome Time Frame:

3 years

Safety Issue:

Yes

Principal Investigator

Rupal Bhatt, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Beth Israel Deaconess Medical Center

Authority:

United States: Institutional Review Board

Study ID:

06-287

NCT ID:

NCT00601120

Start Date:

June 2007

Completion Date:

Related Keywords:

  • Renal Cell Carcinoma
  • antiangiogenic therapy
  • RF ablation
  • Carcinoma
  • Carcinoma, Renal Cell

Name

Location

Beth Israel Deaconess Medical Center Boston, Massachusetts  02215