Comparative Pharmacokinetics of a Compounded 6-mercaptopurine Liquid Formulation Preparation and Tablets
The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2011 by Children's Mercy Hospital Kansas City.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Children's Mercy Hospital Kansas City
Information provided by:
Children's Mercy Hospital Kansas City
ClinicalTrials.gov Identifier:
NCT01324336
First received: March 25, 2011
Last updated: April 8, 2011
Last verified: March 2011
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Purpose
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).
| Condition | Intervention |
|---|---|
|
Acute Lymphoblastic Leukemia |
Drug: 6-Mercaptopurine |
| Study Type: | Observational |
| Study Design: | Observational Model: Case-Crossover Time Perspective: Prospective |
| Official Title: | Comparative Pharmacokinetics of a Compounded 6-mercaptopurine Liquid Formulation Preparation and Tablets |
Resource links provided by NLM:
Further study details as provided by Children's Mercy Hospital Kansas City:
Primary Outcome Measures:
- Pharmacokinetics of 6-MP [ Time Frame: 8 hours post administration ] [ Designated as safety issue: No ]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).
Biospecimen Retention: Samples With DNA
whole blood, plasma, urine
| Estimated Enrollment: | 12 |
| Study Start Date: | October 2010 |
| Groups/Cohorts | Assigned Interventions |
|---|---|
| 6-17 years, receiving 6-MP |
Drug: 6-Mercaptopurine
75 mg/m2/dose/day
Other Name: 6-MP
|
Eligibility| Ages Eligible for Study: | 6 Years to 17 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Study Population
Patients ages 6-17 years of age who are receiving maintenance chemotherapy treatment for ALL with 6-MP will be included
Criteria
Inclusion Criteria:
- Patients ages 6-17 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
- Body-mass index (BMI) < 5th and > 95th percentile
- 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01324336
Contacts
| Contact: Ann M Harris, RN, BSN, MBA | 816-234-3059 | amharris@cmh.edu |
| Contact: Michael Venneman, RN, BSN | 816-234-3059 | mvenneman@cmh.edu |
Locations
| United States, Missouri | |
| The Children's Mercy Hospital | Recruiting |
| Kansas City, Missouri, United States, 64108 | |
| Contact: Ann M Harris, RN, BSN, MBA 816-234-3059 amharris@cmh.edu | |
| Contact: Kathleen A Neville, MD;MS 816-234-3059 kaneville@cmh.edu | |
| Principal Investigator: Kathleen A Neville, MD:MS | |
Sponsors and Collaborators
Children's Mercy Hospital Kansas City
Investigators
| Principal Investigator: | Kathleen A Neville, MD;MS | The Children's Mercy Hospital |
More Information
No publications provided
| Responsible Party: | Kathleen A. Neville, MD, MS, The Children's Mercy Hospital |
| ClinicalTrials.gov Identifier: | NCT01324336 History of Changes |
| Other Study ID Numbers: | 6-MP pharmacokinetic 1 |
| Study First Received: | March 25, 2011 |
| Last Updated: | April 8, 2011 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Children's Mercy Hospital Kansas City:
|
ALL acute lymphoblastic leukemia Hospital Admission Dx Patient Bld-Ser-Plas |
Additional relevant MeSH terms:
|
Leukemia Leukemia, Lymphoid Precursor Cell Lymphoblastic Leukemia-Lymphoma Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases 6-Mercaptopurine Antimetabolites |
Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antimetabolites, Antineoplastic Antineoplastic Agents Therapeutic Uses Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors |
ClinicalTrials.gov processed this record on May 23, 2013