Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified May 2013 by Children's Mercy Hospital Kansas City.
Recruitment status was:  Recruiting
Sponsor:
Collaborators:
Midwest Cancer Alliance
Experimental Therapeutics in Pediatric Oncology Program at The Children's Mercy Hospitals and Clinics
Information provided by (Responsible Party):
Kathleen A Neville, Children's Mercy Hospital Kansas City
ClinicalTrials.gov Identifier:
NCT01324336
First received: March 25, 2011
Last updated: May 31, 2013
Last verified: May 2013
  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-Only
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

Estimated Enrollment: 40
Study Start Date: July 2011
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
4-17 years, receiving 6-MP Drug: 6-Mercaptopurine
75 mg/m2/dose/day
Other Name: 6-MP

  Eligibility

Ages Eligible for Study:   4 Years to 17 Years   (Child)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients ages 4-17 years of age who are receiving maintenance chemotherapy treatment for ALL with 6-MP will be included
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01324336

Locations
United States, Missouri
The Children's Mercy Hospital
Kansas City, Missouri, United States, 64108
Sponsors and Collaborators
Children's Mercy Hospital Kansas City
Midwest Cancer Alliance
Experimental Therapeutics in Pediatric Oncology Program at The Children's Mercy Hospitals and Clinics
Investigators
Principal Investigator: Kathleen A Neville, MD, MS The Children's Mercy Hospitals and Clinics
  More Information

Responsible Party: Kathleen A Neville, MD, MS, Children's Mercy Hospital Kansas City
ClinicalTrials.gov Identifier: NCT01324336     History of Changes
Other Study ID Numbers: 6-MP pharmacokinetic 1 
Study First Received: March 25, 2011
Last Updated: May 31, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Children's Mercy Hospital Kansas City:
ALL
acute lymphoblastic leukemia
6-Mercaptopurine
Pediatric

Additional relevant MeSH terms:
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Leukemia
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
6-Mercaptopurine
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on December 09, 2016