Rasburicase and Allopurinol in Treating Patients With Hematologic Malignancies

Brief Title

Rasburicase and Allopurinol in Treating Patients With Hematologic Malignancies

Official Title

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

Brief 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.
    

Study Phase

Phase 2

Study Type

Interventional

Primary Outcome

Probability of Obtaining a Uric Acid Level =< 7.5mg/dL

Secondary Outcome

 Number of Patients Requiring Additional Doses of Rasburicase to Maintain a Uric Acid Level =< 7.5mg/dL

Condition

Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities

Intervention

rasburicase

Study Arms / Comparison Groups

 Arm I (1.5mg rasburicase)

Description:  Patients receive 1.5mg of rasburicase IV over 30 minutes on day 1 and allopurinol PO QD on days 1-6.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Status

Drug

Estimated Enrollment

24

Start Date

September 29, 2011

Completion Date

May 28, 2016

Primary Completion Date

May 28, 2015

Eligibility Criteria

        Inclusion Criteria:

          -  Eastern Cooperative Oncology Group (ECOG) status of 0-3

          -  Active leukemia and Burkitt leukemia/lymphoma treated in-house that puts them at risk
             for tumor lysis syndrome (TLS)

          -  Serum uric acid level >= 7.5mg/dL and high risk for TLS as defined by:

               -  A diagnosis of acute myeloid leukemia (AML), or

               -  A diagnosis of blast-phase chronic myeloid leukemia (CML), or

               -  A diagnosis of high-grade myelodysplastic syndrome (MDS) with >= 10% blast bone
                  marrow blast involvement, or

               -  Acute lymphoblastic leukemia (ALL), or

               -  Burkitt leukemia/lymphoma

          -  Patient or legal representative must understand the investigational nature of this
             study and sign an Independent Ethics Committee/Institutional Review Board approved
             written informed consent form prior to receiving any study related procedure

        Exclusion Criteria:

          -  History of asthma

          -  History of severe or life threatening atopic allergy

          -  Hypersensitivity to uricases

          -  Known prior sensitivity to allopurinol

          -  Known glucose-6-phosphate dehydrogenase (G6PD) deficiency

          -  Recent prior history of uricolytic therapy defined as therapy within the last 7 days
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Eunice Wang, MD, , 

Location Countries

United States

Location Countries

United States

NCT ID

NCT01564277

Organization ID

I 197711

Secondary IDs

NCI-2011-03231

Responsible Party

Sponsor

Study Sponsor

Roswell Park Cancer Institute

Collaborators

 National Cancer Institute (NCI)

Study Sponsor

Eunice Wang, MD, Principal Investigator, Roswell Park Cancer Institute

Verification Date

December 2017