Effect of Pegloticase on Reduction of Uric Acid in Patients With Tumor Lysis Syndrome: A Pilot Pragmatic Clinical Trial

2020-0330

This trial studies the effect of pegloticase in reducing uric acid levels in patients with hyperuricemia (high blood levels of uric acid) caused by tumor lysis syndrome. Tumor lysis syndrome occurs when the breakdown products of cancer cells, such as uric acid, enter the blood stream. High levels of uric acid in blood may cause kidney damage and reduce kidney function. The goal of this trial is to learn if pegloticase may lower uric acid levels in blood when given to cancer patients with hyperuricemia caused by tumor lysis syndrome.

2022-04-05

2025-12-31

2025-12-31

Recruiting

Early phase I

10

Inclusion Criteria: For inclusion in the study, patients should fulfill the following criteria: 1. Signed informed consent prior to any study specific procedures (patient or caregiver) 2. Male or female 18 years of age or older 3. In the investigator's opinion, expected survival of at least 1 month 4. Deemed stable by the investigator 5. Serum Uric Acid ≥ 6 mg/dL 6. Risk for tumor lysis syndrome based on the MD Anderson TLS risk score Exclusion Criteria: Patients will be ineligible for study enrollment if any of the following exclusion criteria are fulfilled: 1. Inability or refusal to give informed consent (patient or caregiver) 2. Subject unwilling to take study medication 3. Known allergy to uricase 4. Pregnant 5. Breastfeeding 6. Known glucose-6-phosphate dehydrogenase (G6PD) deficiency 7. Transfusion in last 7 days (as this interferes with G6PD test), with the exception of platelet transfusions. 8. Has received rasburicase during current admission.(Can be considered if \>4 days after last Rasburicase administered, current or previous admission)

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 10, 'type': 'ESTIMATED'}}

2024-05-28