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A Pilot Study of Allopurinol As A Modifier of 6-MP Metabolism in Pediatric ALL

Information source: Sidney Kimmel Comprehensive Cancer Center
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Acute Lymphoblastic Leukemia (ALL)

Intervention: Allopurinol (Drug)

Phase: N/A

Status: Recruiting

Sponsored by: Sidney Kimmel Comprehensive Cancer Center

Official(s) and/or principal investigator(s):
Colleen Annesley, MD, Principal Investigator, Affiliation: Johns Hopkins University

Overall contact:
Colleen Annesley, MD, Phone: 410-502-9960, Email: cannesl1@jhmi.edu

Summary

This research is being done to determine if allopurinol can change the metabolism of the oral chemotherapeutic medication 6-mercaptopurine (6-MP) in children with acute lymphoblastic leukemia (ALL). 6-MP is originally started at a standard dose in children with ALL, but the dose is adjusted according to the absolute neutrophil count (ANC). Occasionally, 6-MP doses need to be increased in order to get the ANC into a specific target range. Also, increasing the 6-MP dose can lead to unwanted side effects, such as inflammation of the liver as shown by increases in laboratory values (ALT, aspartate aminotransferase (AST), bilirubin), nausea, and abdominal discomfort. Previous studies in children with inflammatory bowel disease has shown that combining allopurinol with 6-MP can decrease side effects associated with high doses of 6-MP and also increase the efficacy of 6-MP. Allopurinol is approved by the Food and Drug Administration for the treatment of tumor lysis syndrome in ALL. Through this research study, we hope to show that the combination of allopurinol and 6-MP will be safe, tolerable, and effective in children with ALL.

Clinical Details

Official title: A Pilot Study of Allopurinol As A Modifier of 6-MP Metabolism in Pediatric ALL

Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Absolute neutrophil count

Secondary outcome:

Feasibility of the addition of allopurinol to ALL maintenance therapy

Safety of the addition of allopurinol to ALL maintenance therapy

Effects of allopurinol on liver function tests

Alteration of 6-MP metabolism through the addition of allopurinol

Detailed description:

- Patients will have several visits to the Pediatric Oncology outpatient clinic. Each

visit will consist of a physical examination and laboratory evaluation. Each laboratory evaluation will consist of taking approximately 10 to 15 milliliters of blood (or approximately three teaspoons). These clinic visits may actually coincide with clinic visits that were previously scheduled according to the patient's treatment protocol.

- At the first study visit, patients will have a physical examination and laboratory

evaluation. At that visit, patients will be asked to stop taking 6-MP and methotrexate.

- At the second study visit, which is one week later, patients will again have a physical

examination and laboratory evaluation. We will prescribe allopurinol and restart 6-MP and methotrexate at half of the patient's previous doses.

- Clinic visits for physical examination and laboratory evaluation will be scheduled

every 1-2 weeks for a total of 5 more visits. Doses of allopurinol, 6-MP, and methotrexate may be adjusted at these visits based on laboratory values or clinical symptoms.

Eligibility

Minimum age: N/A. Maximum age: 30 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Currently being treated in the maintenance phase of therapy for pediatric ALL

- Age ≤30 years

- 6-MP at ≥125% of initial dose for ≥4 weeks

- ANC persistently ≥1500/mm3 (as measured by 3 complete blood cell counts (CBCs) done

over 6 weeks or 2 successive monthly CBCs)

- Laboratory evidence of hepatotoxicity as evidenced by one of the following: ALT ≥200

units/L (5x upper limit of normal), AST ≥185 units/L (5x upper limit of normal), direct bilirubin ≥2. 0 mg/dL (5x upper limit of normal) Exclusion Criteria:

- Allergy to allopurinol

- Active relapse of ALL

- Currently enrolled on any therapeutic research study for the treatment of ALL

Locations and Contacts

Colleen Annesley, MD, Phone: 410-502-9960, Email: cannesl1@jhmi.edu

Johns Hopkins Hospital, Baltimore, Maryland 21287, United States; Recruiting
Colleen Annesley, MD, Principal Investigator
Patrick A Brown, MD, Sub-Investigator
Additional Information

Starting date: January 2014
Last updated: March 31, 2015

Page last updated: August 23, 2015

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