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

NCT00019955 | Completed Phase 2

• 2 other identifiers: CDR0000067334NCI-99-C-0170
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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).

Conditions

Kidney Cancer

Keywords

stage I renal cell cancer; stage II renal cell cancer

Outcome Measures

Primary Outcomes (1)

• Response

Interventions

laparoscopic surgery PROCEDURE

radiofrequency ablation PROCEDURE

thermal ablation therapy PROCEDURE

Eligibility Criteria

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

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support

Bethesda, Maryland, 20892-1182, United States

Location

Related Publications (11)

• Hwang JJ, Walther MM. Update on minimally invasive approaches to kidney tumors. Curr Urol Rep. 2004 Feb;5(1):13-8. doi: 10.1007/s11934-004-0005-y.

  PMID: 14733831 BACKGROUND

• Pautler SE, Walther MM. Transperitoneal laparoscopic radical nephrectomy for bulky renal tumors. Can J Urol. 2002 Oct;9(5):1653-9; discussion 1660.

  PMID: 12431330 BACKGROUND

• Pavlovich CP, Walther MM, Eyler RA, Hewitt SM, Zbar B, Linehan WM, Merino MJ. Renal tumors in the Birt-Hogg-Dube syndrome. Am J Surg Pathol. 2002 Dec;26(12):1542-52. doi: 10.1097/00000478-200212000-00002.

  PMID: 12459621 BACKGROUND

• Wood BJ, Ramkaransingh JR, Fojo T, Walther MM, Libutti SK. Percutaneous tumor ablation with radiofrequency. Cancer. 2002 Jan 15;94(2):443-51. doi: 10.1002/cncr.10234.

  PMID: 11900230 BACKGROUND

• 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. doi: 10.1007/s00270-004-0062-0. Epub 2004 Jun 3.

  PMID: 15383844 BACKGROUND

• 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.

  PMID: 11564277 BACKGROUND

• 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. doi: 10.1097/01.rvi.0000133535.16753.58.

  PMID: 15231890 BACKGROUND

• 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. doi: 10.1093/jnci/93.8.648. No abstract available.

  PMID: 11309443 BACKGROUND

• Hwang JJ, Walther MM, Pautler SE, Coleman JA, Hvizda J, Peterson J, Linehan WM, Wood BJ. Radio frequency ablation of small renal tumors:: intermediate results. J Urol. 2004 May;171(5):1814-8. doi: 10.1097/01.ju.0000119905.72574.de.

  PMID: 15076283 RESULT

• Pavlovich CP, Walther M, Choyke PL, Pautler SE, Chang R, Linehan WM, Wood BJ. Percutaneous radio frequency ablation of small renal tumors: initial results. J Urol. 2002 Jan;167(1):10-5.

  PMID: 11743264 RESULT

• Walther MC, Shawker TH, Libutti SK, Lubensky I, Choyke PL, Venzon D, Linehan WM. A phase 2 study of radio frequency interstitial tissue ablation of localized renal tumors. J Urol. 2000 May;163(5):1424-7.

  PMID: 10751849 RESULT

MeSH Terms

Conditions

Kidney Neoplasms; Carcinoma, Renal Cell

Interventions

Laparoscopy; Radiofrequency Ablation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Endoscopy; Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative; Radiofrequency Therapy; Therapeutics; Ablation Techniques

Study Officials

• McClellan M. Walther, MD

  NCI - Urologic Oncology Branch

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: NIH

Study Record Dates

• First Submitted: July 11, 2001
• First Posted: January 27, 2003
• Study Start: March 1, 2000
• Last Updated: April 29, 2015

Record last verified: 2005-09

Locations

US (1)