Overview

Pegloticase for the Reduction of Uric Acid in Patients With Tumor Lysis Syndrome

Status:
Not yet recruiting

Trial end date:
2021-09-01

Target enrollment:
0

Participant gender:
All

Summary

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.

Phase:

Phase 4

Accepts Healthy Volunteers?

Details

Lead Sponsor:

M.D. Anderson Cancer Center

Treatments:

Rasburicase
Uric Acid

Criteria

Inclusion Criteria:

- Signed informed consent prior to any study specific procedures (patient or caregiver)

- Male or female 18 years of age or older

- In the investigator's opinion, expected survival of at least 1 month

- Deemed stable by the investigator

- Serum uric acid > 6 mg/dL (measured as average of 3 days prior, +/- 1 days)

- High risk for tumor lysis syndrome based on the MD Anderson Tumor Lysis Syndrome (TLS)
risk score

Exclusion Criteria:

- Inability or refusal to give informed consent (patient or caregiver)

- Subject unwilling to take study medication

- Known allergy to uricase

- Pregnant

- Breastfeeding

- Known glucose-6-phosphate dehydrogenase (G6PD) deficiency or transfusion in last 7
days (as this interferes with G6PD test)