Efficacy and Safety of Two Comparable Single Low Doses of Rasburicase Followed by Allopurinol in Adult Patients with Malignancy

Uric acid is normally formed in the body as a result of the damage of cells. Certain cancers that have a higher cellular turnover rate can cause abnormally high uric levels. This can occur unexpectedly as a result of the rapid cellular turnover in tumors or as a result of the damage of the large number of tumor cells by chemotherapy. If the uric acid levels become to high, it can result in a condition called tumor lysis syndrome. Tumor lysis syndrome occurs when the contents of the cells destroyed by chemotherapy (uric acid as well as potassium and phosphorous) spill into the blood causing untoward effects and complications. One of the complications of hyperuricemia is the crystallization or uric acid in the kidneys causing kidney failure.
There are a number of ways to treat and prevent hyperuricemia. Your physician will give you intravenous fluids to flush the kidneys to prevent the uric acid from crystallizing and causing renal failure. We will use 2 drugs to treat you hyperuricemia.
Allopurinol will help to prevent the formation of uric acid and was approved by the FDA in 1966 for treatment of hyperuricemia.
Rasburicase is a drug that can break down the uric acid that has already been formed, and as a result uric acid levels drop very rapidly (usually within 4 to 6 hours).
There have been reports in the medical literature that show smaller doses of Rasburicase to be as effective as the larger doses recommended by the manufacturer. Rasburicase is a very expensive drug to administer (thousands of dollars). Thus if smaller doses of Rasburicase can be shown to be effective, it would provide a substantial cost savings to the patient and the healthcare system.

Study Number: 

I 197711

Principal Investigator: 
ClinicalTrials.Gov ID: 

To inquire about participating in these studies, call 1-877-ASK-RPCI (1-877-275-7724) or e-mail askrpci@roswellpark.org.