Comparative Pharmacokinetics of a Compounded 6-mercaptopurine Liquid Formulation Preparation and Tablets

• Status: Completed
• Trial end date: 2013-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to compare the pharmacokinetics of a routinely used compounded liquid formulation of 6-mercaptopurine (6-MP) with commercially available tablets in patients who are receiving treatment with 6-MP as part of their clinical treatment for acute lymphoblastic leukemia (ALL).

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Children's Mercy Hospital Kansas City
• Collaborators: Experimental Therapeutics in Pediatric Oncology Program at The Children's Mercy Hospitals and Clinics; Midwest Cancer Alliance
• Treatments: 6-Mercaptopurine; Mercaptopurine

Criteria

Inclusion Criteria:

• Patients ages 4-17 years of age who are receiving maintenance chemotherapy treatment for ALL with 6-MP will be included.

Exclusion Criteria:

• Inability to have blood drawn for the screening lab tests

• Received methotrexate or folate supplement within the last 24 hours

• Pregnant or lactating females

• Inability to swallow a pill

• Hemoglobin less or equal to 8 gm/dl

• Presence of significant co-morbid illness that makes child ineligible as deemed by the investigator

• Weight < or = 16 kg