Hematopoietic and Lymphoid Cell Neoplasm, Malignant Solid Neoplasm, Tumor Lysis Syndrome
Conditions
Brief 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.
Detailed 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.
Interventions
DRUGPegloticase
Given IV
DRUGRasburicase
Given IV
Sponsors
M.D. Anderson Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Response rate | Within 24 hours of single dose of pegloticase | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time from pegloticase infusion until serum uric acid levels drop to 6 mg/dL | Up to 14 days after pegloticase administration | Will display results in frequency tables and plots of serum uric acid levels across time. |
| Renal function | Up to 14 days after pegloticase administration | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Serum uric acid level | Up to 14 days after pegloticase administration | 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. |
Countries
United States
Outcome results
None listed