Rasburicase and Allopurinol in Treating Patients With Hematologic Malignancies
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Purpose
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
| Condition | Intervention | Phase |
|---|---|---|
|
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 |
Drug: rasburicase Drug: allopurinol |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Efficacy and Safety of Two Comparable Single Low Doses of Rasburicase Followed by Allopurinol in Adult Patients With Malignancy |
- Probability of obtaining a uric acid level =< 7.5mg/dL [ Time Frame: Within 24 hours of rasburicase treatment ] [ Designated as safety issue: No ]The sample proportion responding and the lower one-sided Wilson Score confidence limits will be calculated for each treatment arm. Other descriptive statistics and graphical comparisons will be provided as needed.
- Rate of patients that maintain a uric acid level =< 7.5mg/dL [ Time Frame: Days 2-6 following a single dose of rasburicase ] [ Designated as safety issue: No ]The sample proportion responding and the lower one-sided Wilson Score confidence limits will be calculated for each treatment arm. Other descriptive statistics and graphical comparisons will be provided as needed.
- Rate of patients requiring additional doses of rasburicase to maintain a uric acid level =< 7.5mg/dL [ Time Frame: Days 2-6 ] [ Designated as safety issue: No ]The sample proportion responding and the lower one-sided Wilson Score confidence limits will be calculated for each treatment arm. Other descriptive statistics and graphical comparisons will be provided as needed.
- Comparison of rate of patients able to maintain a uric acid level =< 7.5mg/dL between the two treatment arms [ Time Frame: Days 2-6 ] [ Designated as safety issue: No ]The sample proportion responding and the lower one-sided Wilson Score confidence limits will be calculated for each treatment arm. Other descriptive statistics and graphical comparisons will be provided as needed.
- Identification and comparison of differential characteristics of patients unable to achieve and/or maintain a uric acid level =< 7.5mg/dL [ Time Frame: Days 2-6 ] [ Designated as safety issue: No ]The sample proportion responding and the lower one-sided Wilson Score confidence limits will be calculated for each treatment arm. Other descriptive statistics and graphical comparisons will be provided as needed.
| Estimated Enrollment: | 36 |
| Study Start Date: | September 2011 |
| Estimated Primary Completion Date: | July 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Arm I (1.5mg rasburicase)
Patients receive 1.5mg of rasburicase IV over 30 minutes on day 1 and allopurinol PO QD on days 1-6.
|
Drug: rasburicase
Given IV
Other Names:
Drug: allopurinol
Given PO
Other Names:
|
|
Experimental: Arm II (3 mg rasburicase)
Patients receive 3 mg of rasburicase IV over 30 minutes on day 1 and allopurinol PO QD on days 1-6.
|
Drug: allopurinol
Given PO
Other Names:
Drug: rasburicase
Given IV
Other Names:
|
Detailed Description:
PRIMARY OBJECTIVES:
I. To prospectively evaluate the efficacy, as defined by uric acid response rate, of 2 different 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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| United States, New York | |
| Roswell Park Cancer Institute | Recruiting |
| Buffalo, New York, United States, 14263 | |
| Contact: Roswell Park 877-275-7724 AskRPCI@roswellpark.org | |
| Principal Investigator: Meir Wetzler | |
| Principal Investigator: | Meir Wetzler | Roswell Park Cancer Institute |
More Information
No publications provided
| Responsible Party: | Roswell Park Cancer Institute |
| ClinicalTrials.gov Identifier: | NCT01564277 History of Changes |
| Other Study ID Numbers: | I 197711, NCI-2011-03231 |
| Study First Received: | March 2, 2012 |
| Last Updated: | March 11, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Congenital Abnormalities Blast Crisis Burkitt Lymphoma Leukemia Leukemia, Lymphoid Precursor Cell Lymphoblastic Leukemia-Lymphoma Leukemia, Myeloid, Acute Leukemia, Myeloid Leukemia, Myelogenous, Chronic, BCR-ABL Positive Lymphoma Myelodysplastic Syndromes Preleukemia Hematologic Neoplasms Neoplasms by Histologic Type Neoplasms |
Cell Transformation, Neoplastic Neoplastic Processes Myeloproliferative Disorders Bone Marrow Diseases Hematologic Diseases Pathologic Processes Epstein-Barr Virus Infections Herpesviridae Infections DNA Virus Infections Virus Diseases Tumor Virus Infections Lymphoma, Non-Hodgkin Lymphoma, B-Cell Neoplasms, Experimental Lymphoproliferative Disorders |
ClinicalTrials.gov processed this record on May 23, 2013