Radiofrequency Interstitial Tissue Ablation in Treating Patients With Localized Renal Cell Carcinoma (Kidney Cancer)

• Sponsor: National Cancer Institute (NCI) (NIH)
• Overall Status: Completed
• CT.gov ID: NCT00019955
• Collaborator: (none)
• Location: 1

Study Details

Study Description

Brief Summary

RATIONALE: Radiofrequency interstitial tissue ablation may kill tumor cells by heating tumors to several degrees above body temperature.

PURPOSE: This phase II trial is studying radiofrequency interstitial tissue ablation to see how well it works in treating patients with localized renal cell carcinoma (kidney cancer).

Condition or Disease	Intervention/Treatment	Phase
Kidney Cancer	Procedure: laparoscopic surgery; Procedure: radiofrequency ablation; Procedure: thermal ablation therapy	Phase 2

Detailed Description

OBJECTIVES:

Primary

• Evaluate the efficacy of radiofrequency interstitial tissue ablation in terms of tumor destruction or slowed tumor growth rate in patients with localized renal cell carcinoma.

Secondary

• Assess the toxicity of this treatment regimen in these patients.

OUTLINE: Patients undergo percutaneous radiofrequency interstitial tumor ablation (RFA). Patients are offered laparoscopy-assisted percutaneous RFA in the operating room if their tumors are not safely accessible. Intra-operative ultrasound is used to confirm probe placement and to monitor treatment delivery. If the target temperature or impedance are not reached, treatment is repeated no more than twice. No more than 5 tumors are treated per kidney.

All patients are followed at 2 to 3 months, 6 months, and then at 1 year.

Patients with tumors greater than 2 cm in diameter are followed every 6 months for up to 5 years. Patients whose tumors become greater than 3 cm are recommended for surgery and removed from study if surgery is performed.

PROJECTED ACCRUAL: A total of 63 patients will be accrued for this study within 1 year.

Study Design

• Study Type: Interventional
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase II Study to Evaluate Radiofrequency Ablation of Renal Cancer
• Study Start Date: Mar 1, 2000

Outcome Measures

Primary Outcome Measures

1. Response []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

DISEASE CHARACTERISTICS:

• Localized renal cell carcinoma, meeting both of the following criteria:

• Enlarging renal tumors on imaging studies over a minimum of 12 months

• Tumor size between 0.5-4.0 cm in diameter at time of treatment

PATIENT CHARACTERISTICS:

Age:

• 18 and over

Performance status:

• Not specified

Life expectancy:

• Not specified

Hematopoietic:

• Not specified

Hepatic:

• Not specified

Renal:

• Creatinine less than 2.0 mg/dL OR

• Creatinine clearance greater than 60 mL/min

Other:

• Not pregnant

• Negative pregnancy test

PRIOR CONCURRENT THERAPY:

Biologic therapy

• Not specified

Chemotherapy

• Not specified

Endocrine therapy

• Not specifed

Radiotherapy

• Not specified

Surgery

• Not specified

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support	Bethesda	Maryland	United States	20892-1182

Sponsors and Collaborators

• National Cancer Institute (NCI)

Investigators

• Study Chair: McClellan M. Walther, MD, NCI - Urologic Oncology Branch

Study Documents (Full-Text)

None provided.

More Information

Publications

• Friedman M, Mikityansky I, Kam A, Libutti SK, Walther MM, Neeman Z, Locklin JK, Wood BJ. Radiofrequency ablation of cancer. Cardiovasc Intervent Radiol. 2004 Sep-Oct;27(5):427-34. Epub 2004 Jun 3. Review.
• Hwang JJ, Walther MM. Update on minimally invasive approaches to kidney tumors. Curr Urol Rep. 2004 Feb;5(1):13-8. Review.
• Kam AW, Littrup PJ, Walther MM, Hvizda J, Wood BJ. Thermal protection during percutaneous thermal ablation of renal cell carcinoma. J Vasc Interv Radiol. 2004 Jul;15(7):753-8.
• Pacak K, Fojo T, Goldstein DS, Eisenhofer G, Walther MM, Linehan WM, Bachenheimer L, Abraham J, Wood BJ. Radiofrequency ablation: a novel approach for treatment of metastatic pheochromocytoma. J Natl Cancer Inst. 2001 Apr 18;93(8):648-9.
• Pautler SE, Pavlovich CP, Mikityansky I, Drachenberg DE, Choyke PL, Linehan WM, Wood BJ, Walther MM. Retroperitoneoscopic-guided radiofrequency ablation of renal tumors. Can J Urol. 2001 Aug;8(4):1330-3.
• Pautler SE, Walther MM. Transperitoneal laparoscopic radical nephrectomy for bulky renal tumors. Can J Urol. 2002 Oct;9(5):1653-9; discussion 1660. Review.
• Pavlovich CP, Walther MM, Eyler RA, Hewitt SM, Zbar B, Linehan WM, Merino MJ. Renal tumors in the Birt-Hogg-Dubé syndrome. Am J Surg Pathol. 2002 Dec;26(12):1542-52.
• Wood BJ, Ramkaransingh JR, Fojo T, Walther MM, Libutti SK. Percutaneous tumor ablation with radiofrequency. Cancer. 2002 Jan 15;94(2):443-51. Review.

• ClinicalTrials.gov Identifier: NCT00019955
• Other Study ID Numbers: CDR0000067334; NCI-99-C-0170; NCT00001834
• First Posted: Jan 27, 2003
• Last Update Posted: Apr 29, 2015
• Last Verified: Sep 1, 2005

• Keywords provided by , ,: stage I renal cell cancer; stage II renal cell cancer
• Additional relevant MeSH terms: Kidney Neoplasms; Carcinoma, Renal Cell

Study Results

No Results Posted as of Apr 29, 2015