Kidney Cancer Clinical Trial

Percutaneous Renal Tumor Cryoablation Followed by Biopsy

Summary

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.

View Eligibility Criteria

Eligibility Criteria

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 or as clinically indicated.
The following laboratory results should be within the following limits within the last 30 days 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.

Study is for people with:

Kidney Cancer

Phase:

Phase 1

Estimated Enrollment:

17

Study ID:

NCT01012427

Recruitment Status:

Completed

Sponsor:

Memorial Sloan Kettering Cancer Center

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There is 1 Location for this study

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Memorial Sloan Kettering Cancer Center
New York New York, 10065, United States

How clear is this clinincal trial information?

Study is for people with:

Kidney Cancer

Phase:

Phase 1

Estimated Enrollment:

17

Study ID:

NCT01012427

Recruitment Status:

Completed

Sponsor:


Memorial Sloan Kettering Cancer Center

How clear is this clinincal trial information?

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