NCT01564277

Rasburicase and Allopurinol in Treating Patients With Hematologic Malignancies

Efficacy and Safety of Two Comparable Single Low Doses of Rasburicase Followed by Allopurinol in Adult Patients With Malignancy

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Roswell Park Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This randomized phase II trial studies how well giving rasburicase together with allopurinol works in treating patients with hematologic malignancies. Rasburicase may reduce the level of uric acid in the blood. Allopurinol may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. It is not yet known which dose of rasburicase is more effective in treating hematologic malignancies when given together with or without allopurinol.

Detailed description

PRIMARY OBJECTIVES: I. To prospectively evaluate the efficacy, as defined by uric acid response rate, of 2 different single low doses of rasburicase followed by allopurinol in 2 treatment arms. SECONDARY OBJECTIVES: I. To estimate the proportion of patients requiring additional doses of rasburicase to maintain a uric acid level =\< 7.5mg/dL on day 2 through day 6. II. To identify differential characteristics of the patients who do not respond to treatment. III. To measure the area under the plasma uric acid concentration-time curve (AUC) from baseline (day 1) to day 7, time to plasma uric acid level less than or equal to 7.5mg/dL. IV. To evaluate the rate of patients requiring hemodialysis (HD) V. To evaluate the safety of low single-doses of rasburicase. VI. To evaluate the rate of patients expressing a doubling of serum creatinine. OUTLINE: Patients are randomized to 1 of 2 treatment arms. ARM I: Patients receive 1.5mg of rasburicase intravenously (IV) over 30 minutes on day 1\* and allopurinol orally (PO) once daily (QD) on days 1-6. ARM II: Patients receive 3 mg of rasburicase IV over 30 minutes on day 1\* and allopurinol PO QD on days 1-6. NOTE: \*Patients with serum uric acid \>= 7.5mg/dl also receive rasburicase IV on days 2-3. After completion of study treatment, patients are followed up at 30 days.

Conditions

• Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities
• Adult Acute Myeloid Leukemia With Del(5q)
• Adult Acute Myeloid Leukemia With Inv(16)(p13;q22)
• Adult Acute Myeloid Leukemia With t(15;17)(q22;q12)
• Adult Acute Myeloid Leukemia With t(16;16)(p13;q22)
• Adult Acute Myeloid Leukemia With t(8;21)(q22;q22)
• Blastic Phase Chronic Myelogenous Leukemia
• Contiguous Stage II Adult Burkitt Lymphoma
• de Novo Myelodysplastic Syndromes
• Noncontiguous Stage II Adult Burkitt Lymphoma
• Previously Treated Myelodysplastic Syndromes
• Recurrent Adult Acute Lymphoblastic Leukemia
• Recurrent Adult Acute Myeloid Leukemia
• Recurrent Adult Burkitt Lymphoma
• Stage I Adult Burkitt Lymphoma
• Stage III Adult Burkitt Lymphoma
• Stage IV Adult Burkitt Lymphoma
• Untreated Adult Acute Lymphoblastic Leukemia
• Untreated Adult Acute Myeloid Leukemia

Interventions

Type	Name	Description
DRUG	rasburicase	Given IV
DRUG	allopurinol	Given PO

Timeline

• Start date: 2011-09-29
• Primary completion: 2015-05-28
• Completion: 2016-05-28
• First posted: 2012-03-27
• Last updated: 2018-01-09
• Results posted: 2017-12-08

Locations

1 site across 1 country: United States