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

M.D. Anderson Cancer Center logo

M.D. Anderson Cancer Center

Status and phase

Enrolling
Phase 4

Conditions

Tumor Lysis Syndrome
Hematopoietic and Lymphoid Cell Neoplasm
Malignant Solid Neoplasm

Treatments

Drug: Rasburicase
Drug: Pegloticase

Study type

Interventional

Funder types

Other

Identifiers

NCT04745910
2020-0330 (Other Identifier)
NCI-2020-13890 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment

10 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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)

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

10 participants in 1 patient group

Treatment (pegloticase)
Experimental group
Description:
Patients receive pegloticase 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 QD for 5 days.
Treatment:
Drug: Pegloticase
Drug: Rasburicase

Trial contacts and locations

1

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Central trial contact

Sreedhar Mandayam, MD

Data sourced from clinicaltrials.gov

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