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Home > "E" Clinical Trials Conditions > Electrocautery for Kidney Cancer  Electrocautery for Kidney Cancer
Electrocautery for Kidney Cancer
For Condition: Kidney Neoplasm
Status: Recruiting
Sponsor(s): National Cancer Institute (NCI) ,
Synopsis: This study will examine the safety and effectiveness of electrocautery in treating kidney cancer. Electrocautery is a non-surgical procedure that uses heat to kill the tumor. Some patients are not good surgery candidates because of age, health reasons, or the need for dialysis following surgery. Patients whose tumor cells are destroyed by electrocautery may not need surgery, or may have their surgery delayed. Patients with kidney tumors from 0.5 to 3.0 cm in size will be screened for eligibility in the study with a history and physical examination, CT scan, chest X-ray and blood tests. Study patients will then have their tumors cauterized using a needle device approved by the Food and Drug Administration for treating soft tissues. The patient first receives a local anesthetic in the area of the back where the needle, or needles, are inserted through the skin into the tumor. (A separate needle stick may be used for each tumor treated.) After insertion, the needles are heated to 85 to 105 degrees centigrade (185 to 221 degrees Fahrenheit) for 10 minutes. A thermometer then measures the temperature of the tumor tissue. If the tumor has not been heated to 60 degrees centigrade (140 degrees Fahrenheit), it may be reheated up to two more times to reach that temperature. Patients will be evaluated after the treatment for any complications, similar to those that may occur after surgery. From 1 to 6 months after the procedure, patients will have a CT scan of the abdomen, nuclear medicine kidney scan, and blood or urine tests to evaluate kidney function and tumor growth, if any. These tests will be repeated a year after treatment.
Details: Radiofrequency ablation (RFA) devices are commercially available for the treatment of soft tissue lesions. These devices use standard electrocautery to heat and destroy tissue. The largest experience with these devices has been in treating patients with liver tumors. There is already a large experience using standard electrocautery devices on the kidney. We plan to evaluate the responses of renal cancer to treatment with radiofrequency ablation, prior to planning open surgical resection of these tumors. Patients will be followed after percutaneous treatment to evaluate therapeutic effect and toxicity.
Eligibility:
Study Type: Interventional, Treatment, Safety/Efficacy
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: INCLUSION CRITERIA: Ages 18 and older; and localized renal cancer; and creatinine less than 2.0 mg/dl or creatinine clearance greater than 60 ml/min; and renal tumors seen to enlarge on imaging studies over a minimum of 12 months; and tumor size between 0.5 and 3.0 cm in diameter at time of treatment. Occasionally, RFA is anticipated for patients whose tumors are less than 3cm. We generally follow these subjects until tumor size is appropriate for the procedure. Infrequently, at follow-up, tumor size exceeds 3.0cm. In these instances, in which ablation has been planned, we will allow ablation of tumors up to 4cm. in size. Patients may be retreated if there is initial tumor shrinkage of treated tumors or there is tumor growth of a treated tumor over at least one year or if untreated tumors grow in patients with previously treated tumors. EXCLUSION CRITERIA: Renal tumors smaller than 0.5 cm in diameter or renal tumors larger than 3.0 cm in diameter or pregnancy. Tumors which have been awaiting ablation, and found unexpectedly at follow-up to be between 3.0cm and 4.0cm will be eligible for ablation.
Total Enrollment: 111
Location and Contact Information:
National Cancer Institute (NCI) *Recruiting*
Bethesda, Maryland, 20892
United States
Recruiting Clinical Support Center/NCI 1-888-624-1937
Additional Information:
Study ID Numbers: 990170; 99-C-0170
Study Start Date: September 8, 1999
Record last reviewed: August 1, 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00001834
Other Kidney Neoplasm Studies:
1. CTLA-4 Antibody (MDX-010) to Treat Advanced Kidney Cancer
2. A Phase I Study of Infusional Chemotherapy with the P-Glycoprotein Antagonist PSC 833
3. Electrocautery for Kidney Cancer
Related Studies:
Other Kidney Neoplasm Clinical Trials
Other Maryland Clinical Trials
Other Bethesda Clinical Trials
Electrocautery for Kidney Cancer
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