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

Description

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.

Conditions

Hematopoietic and Lymphoid Cell Neoplasm, Malignant Solid Neoplasm, Tumor Lysis Syndrome

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Hematopoietic and Lymphoid Cell Neoplasm
Intervention / Treatment

-

Contacts and Locations

Houston

M D Anderson Cancer Center, Houston, Texas, United States, 77030

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • 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 i24 hours after last Rasburicase administered, current or previous admission)

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

M.D. Anderson Cancer Center,

Sreedhar Mandayam, MD, PRINCIPAL_INVESTIGATOR, M.D. Anderson Cancer Center

Study Record Dates

2025-12-31