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

Malignant Solid Neoplasm Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04745910
• Other study ID #: 2020-0330
• Secondary ID: NCI-2020-1389020
• Status: Recruiting
• Phase: Phase 4
• Start date: April 5, 2022
• Est. completion date: December 31, 2025

Study information

• Verified date: May 2024
• Source: M.D. Anderson Cancer Center
• Contact: Sreedhar Mandayam, MD
• Phone: 713-745-8597
• Email: samandayam[@]mdanderson.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

PRIMARY OBJECTIVE:

I. To collect preliminary data on the effectiveness of a single dose of pegloticase in lowering serum uric acid levels to less than 6.0 mg/dl within 24 hours in patients with hyperuricemia in the setting of tumor lysis syndrome.

SECONDARY OBJECTIVES:

I. To assess the effect of pegloticase on renal function in patients with hyperuricemia in the setting of tumor lysis syndrome as measured by changes in serum creatinine/estimated glomerular filtration rate (eGFR) and urine output.

II. To estimate the rate of renal replacement therapy initiation for acute kidney injury secondary to tumor lysis syndrome among patients treated with pegloticase.

OUTLINE:

Patients receive pegloticase intravenously (IV) over 120 minutes. Patients whose serum uric acid does not drop below 6 mg/dL within 24 hours receive a second dose of pegloticase IV over 120 minutes on day 2. Patients whose serum uric acid does not drop below 6 mg/dL after two doses of pegloticase receive standard of care rasburicase IV once daily (QD) for 5 days.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Hematopoietic and Lymphoid Cell Neoplasm
• Malignant Solid Neoplasm
• Neoplasms
• Syndrome
• Tumor Lysis Syndrome

Intervention

Drug:
• Pegloticase
Given IV
• Rasburicase
Given IV

Locations

Country	Name	City	State
United States	M D Anderson Cancer Center	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Serum uric acid level	Will examine the association of baseline characteristics with serum uric acid level using the Fisher's exact test, student's t-test, paired t-test, Wilcoxon rank-sum test, or Wilcoxon signed-rank test and will employ graphical methods when useful.	Up to 14 days after pegloticase administration
Primary	Response rate	Will estimate the 24-hour response rate along with the corresponding 90% confidence interval. In addition, the report will present plots of uric acid levels across all time points.	Within 24 hours of single dose of pegloticase
Secondary	Time from pegloticase infusion until serum uric acid levels drop to 6 mg/dL	Will display results in frequency tables and plots of serum uric acid levels across time.	Up to 14 days after pegloticase administration
Secondary	Renal function	Will summarize serum creatinine and estimated glomerular filtration rate at each time point and plot these lab values across time. Finally, will calculate the rate and 90% confidence interval for the initiation of renal replacement therapy within the 14-day observation window.	Up to 14 days after pegloticase administration

External Links

•   M D Anderson Cancer Center