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

NCT00601120 | Withdrawn DMC

• 1 other identifier: 06-287
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Renal Cell Carcinoma

Keywords

antiangiogenic therapy; RF ablation

Outcome Measures

Primary Outcomes (1)

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

  3 years

Secondary Outcomes (4)

• To evaluate the efficacy of RF ablation by measurement of diameter of ablation for treatment in this patient population.

  3 years

• To evaluate relative efficacy of RFA in treatment of metastatic lesions showing sensitivity vs. resistance to anti-angiogenic therapy.

  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.

  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.

  3 years

Interventions

Radiofrequency Ablation PROCEDURE

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.

Also known as: RF Ablation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Beth Israel Deaconess Medical Center: lead

Study Sites (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Carcinoma, Renal Cell

Interventions

Radiofrequency Ablation

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Radiofrequency Therapy; Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Study Officials

• Rupal Bhatt, MD

  Beth Israel Deaconess Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prinicipal Investigator

Study Record Dates

• First Submitted: January 15, 2008
• First Posted: January 25, 2008
• Study Start: June 1, 2007
• Primary Completion: June 1, 2010
• Last Updated: February 27, 2013

Record last verified: 2013-02

Locations

US (1)