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.
|United States, Tennessee|
|Vanderbilt-Ingram Cancer Center - Cool Springs|
|Nashville, Tennessee, United States, 37064|
|Vanderbilt-Ingram Cancer Center|
|Nashville, Tennessee, United States, 37232-6838|
|Principal Investigator:||Adam J. Esbenshade, MD||Vanderbilt-Ingram Cancer Center|
|Investigator:||Kathleen M. Von Wahlde||Vanderbilt-Ingram Cancer Center|