Phase IV Randomized Study of Rasburicase Alone Versus Rasburicase and Allopurinol Versus Allopurinol Alone in Patients With Leukemia, Lymphoma, or Solid Tumor Malignancy at Risk for Hyperuricemia and Tumor Lysis Syndrome
|Phase IV||Supportive care||Closed||18 and over||Pharmaceutical / Industry||PROLOGUE-EFC4978|
Giving rasburicase and/or allopurinol with chemotherapy has been effective in preventing or controlling high levels of uric acid in the blood and tumor lysis syndrome. It is not yet known whether rasburicase and allopurinol are more effective alone or when given sequentially in preventing these problems in patients who are receiving chemotherapy for cancer.
This randomized phase IV trial is studying giving rasburicase together with allopurinol to see how well it works compared to rasburicase alone or allopurinol alone in preventing or controlling high levels of uric acid in the blood and tumor lysis syndrome in patients who are receiving chemotherapy for leukemia, lymphoma, or solid tumors.
Eligibility criteria include the following:
- At least 18 years old
- No previous rasburicase
- For more information about the eligibility criteria for this trial, refer to the Health Professional version.
Final eligibility for a clinical trial is determined by the health professionals conducting the trial.
Patients will be randomly assigned to one of three groups. Patients in group one will receive an infusion of rasburicase once a day for 5 days. Patients in group two will receive an infusion of rasburicase on days 1-3 and allopurinol by mouth once a day on days 3-5. Patients in group three will receive allopurinol by mouth once a day for 5 days.
Patients in all groups will also receive chemotherapy beginning 4-24 hours after the first dose of rasburicase and/or allopurinol.
Patients will be evaluated at 1 week, at 1, 3 and 6 months, and every 6 months thereafter.
For more details about this trial, refer to the Health Professional version of the trial summary.
If you are interested in participating in a clinical trial, contact your doctor for a referral or call a trial contact person listed below. You may see the same contact person listed at more than one site, however, if you call the number listed you can ask to speak to the study coordinator or person involved with the specific trial you are interested in. If you have questions about cancer or clinical trials, call the Cancer Information Service at 1-800-4-CANCER (1-800-422-6237). General information about clinical trials, including risks, benefits, and costs, can be found on NCI's Web site.
Trial Lead Organizations
Prologue Research International, Incorporated
|Richard Gams, MD, Protocol chair|
|Official Title||Evaluation of Single Agent Rasburicase for 5 Days Versus Sequential Treatment with Rasburicase from Day 1 Through 3 Followed by Oral Allopurinol from Day 3 Through 5 (Overlap on Day 3) Versus Single Agent Oral Allopurinol for 5 Days in the Management of Plasma Uric Acid in Adult Patients with Leukemia, Lymphoma, and Solid Tumor Malignancies at Risk for Hyperuricemia and Tumor Lysis Syndrome|
|Registered in ClinicalTrials.gov||NCT00230178|
|Date Submitted to PDQ||2004-05-17|
|Information Last Verified||2008-01-09|