Official Title: “Percutaneous Renal Tumor Cryoablation Followed by Biopsy”

This study is being done to test how effective cryoablation is in killing cancer cells.

Cryoablation uses freezing temperatures to treat cancer. Cryoablation works by creating freezing temperatures within a needle probe. When this probe is inserted into a cancer, the freezing temperatures are used to try and kill the cancer. Unfortunately, the investigators don't know how well cryoablation works at destroying the cancer. This study will allow us to check to see how well cryoablation works for kidney cancers. After the investigators destroy the kidney cancers using cryoablation, the investigators will followup with you every 5-7 months to make sure the cryoablation worked and that the cancer was destroyed.

Study Type: Interventional

Study Design: Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study

Study Primary Completion Date: November 2011

Intervention(s) in this Clinical Trial

• Procedure: percutaneous cryoablation
  • All patients will have percutaneous image guided core biopsies of the treatment site at approximately 5-7 months. They will have repeat imaging at 12, 18, and 24 months (+/- 1 month), and if a there is evidence of recurrence (ablation zone increase > 5 mm or increased enhancement 15 HU), then repeat biopsy will be obtained. Imaging follow-up will then be at 5-7 month intervals up to the two year point and then will be at the discretion of the patient's physicians.

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: Patients with 3.0 cm or smaller renal cancer
  • The interventions in this study are part of clinical care and include percutaneous image-guided biopsy, percutaneous renal tumor cryoablation, CT/MR imaging of the ablation bed, and repeat pathologic sampling of the tumor bed with percutaneous biopsy. The cryoablation is done as the therapeutic intervention in patients with small renal cancer. The CT/MR imaging is done to evaluate the treatment for residual disease after the ablation. The repeat biopsy (e.g. three cores) is done to confirm that the neoplasm has been eradicated. These patients have continued imaging, and if necessary, percutaneous biopsy to ensure no recurrent disease.

Primary Measures

• To determine the efficacy rate after percutaneous renal cryoablation.
  • Time Frame: 2 years
    Safety Issue?: No

Secondary Measures

• To determine the complication rate of percutaneous renal tumor cryoablation.
  • Time Frame: 2 years
    Safety Issue?: Yes
• To correlate post-treatment imaging parameters of CT/MR with therapeutic cryoablation success.
  • Time Frame: 2 years
    Safety Issue?: No
• To assess the glomerular filtration rate changes associated with percutaneous renal cryoablation.
  • Time Frame: 2 years
    Safety Issue?: No
• To investigate predictors of efficacy after cryoablation.
  • Time Frame: 2 years
    Safety Issue?: No

Inclusion Criteria:

• Presence of at least one renal cancer smaller than or equal to 3.0 cm
• Adequate baseline imaging studies (CT/MRI) within 8 weeks of treatment
• The following laboratory results should be within the following limits within the last 2 weeks prior to study day 1. Repeat blood work will be necessary if too much time has elapsed prior to the interventions.:
• Absolute neutrophil count (ANC) ≥ 1.5 x 109/L
• Platelet count ≥ 100 x 109/L
• Serum bilirubin ≤ 2.0 mg/dL
• Aspartate aminotransaminase (AST) ≤ 2.5 x ULN
• Alanine aminotransferase (ALT) ≤ 2.5 x ULN
• Serum creatinine ≤ 2.0 mg/dL
• GFR <30 mL/min/m2
• International Normalized Ratio < 1.5 (INR)
• Partial Thromboplastin Time (PTT) <45 seconds
• Recovered from toxicity of any prior therapy
• Tumor accessible to probe placement without risk to adjacent critical structures.
• Tumor visible on non-contrast CT
• Patient willing and able to undergo imaging and percutaneous biopsy at 5-7 month intervals for 2 years and then at the discretion of the patient's physicians.

Exclusion Criteria:

• Intercurrent medical condition that renders the patient ineligible for cryoablation
• Women who are pregnant or breastfeeding.
• Tumor less than 5 mm to the renal pelvis, main renal vessel, ureter, or other vital structure
• Contraindication to MRI in patients in which it is required.
• Coagulopathy as defined above (Inclusion Criteria).
• Patients unwilling to return for follow-up biopsy and imaging.
• Patients with multiple renal masses.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 21 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Memorial Sloan-Kettering Cancer Center

Overall Clinical Trial Officials and Contacts

Stephen Solomon, MD Principal Investigator Memorial Sloan-Kettering Cancer Center  

Overall Contact: Stephen Solomon, MD 212-639-6610 

Information obtained from ClinicalTrials.gov on February 04, 2010

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT01012427

Study ID Number: 09-108

ClinicalTrials.gov Identifier: NCT01012427

Health Authority: United States: Institutional Review Board

Memorial Sloan-Kettering Cancer Center