Methemoglobinemia in Patients With Childhood Hematologic Cancer or Aplastic Anemia Treated With Dapsone
RATIONALE: Gathering information about patients with childhood hematologic cancer or aplastic anemia treated with dapsone may help doctors learn more about risk factors for developing methemoglobinemia.
PURPOSE: This phase I trial is studying methemoglobinemia in patients with childhood hematologic cancer or aplastic anemia treated with dapsone.
Genetic: polymorphism analysis
Other: laboratory biomarker analysis
Other: medical chart review
Procedure: assessment of therapy complications
|Official Title:||Dapsone Induced Methemoglobinemia Study (DIMS)|
- Age, sex, and body mass index as host-related risk factors for developing symptomatic methemoglobinemia [ Designated as safety issue: No ]
- Cytochrome b5 reductase levels [ Designated as safety issue: No ]
|Study Start Date:||June 2009|
|Estimated Primary Completion Date:||May 2015 (Final data collection date for primary outcome measure)|
- Determine host-related risk factors for developing symptomatic methemoglobinemia in patients with pediatric hematologic malignancies or aplastic anemia who received dapsone prophylaxis for pneumocystis carinii.
- Determine whether a deficiency in cytochrome b5 reductase is a risk factor for symptomatic methemoglobinemia in a subset of these patients.
- Collect a genomic DNA specimen from a subset of patients for whom enzyme testing is being conducted to store for future analyses of variations in the genes responsible for cytochrome b5 reductase.
OUTLINE: Patients' medical records are reviewed for possible risk factors (e.g., age, sex, and body mass index) for developing symptomatic methemoglobinemia.
A subset of patients undergo blood sample collection for analysis of cytochrome b5 reductase levels. DNA samples are also collected from these patients for future genetic polymorphism studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00960050
|United States, Tennessee|
|Vanderbilt-Ingram Cancer Center|
|Nashville, Tennessee, United States, 37232-6838|
|Vanderbilt-Ingram Cancer Center - Cool Springs|
|Nashville, Tennessee, United States, 37064|
|Principal Investigator:||Adam J. Esbenshade, MD||Vanderbilt-Ingram Cancer Center|
|Investigator:||Kathleen M. Von Wahlde||Vanderbilt-Ingram Cancer Center|