Methemoglobinemia in Patients With Childhood Hematologic Cancer or Aplastic Anemia Treated With Dapsone
This trial is active, not recruiting.
|Conditions||leukemia, lymphoma, methemoglobinemia, nonmalignant neoplasm|
|Treatments||polymorphism analysis, laboratory biomarker analysis, medical chart review, assessment of therapy complications|
|Sponsor||Vanderbilt-Ingram Cancer Center|
|Collaborator||National Cancer Institute (NCI)|
|Start date||June 2009|
|End date||May 2015|
|Trial size||173 participants|
|Trial identifier||NCT00960050, CDR0000651820, VU-VICC-PED-0937|
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.
|United States||No locations recruiting|
|Other Countries||No locations recruiting|
Age, sex, and body mass index as host-related risk factors for developing symptomatic methemoglobinemia
Cytochrome b5 reductase levels
Male or female participants up to 22 years old.
DISEASE CHARACTERISTICS: - Diagnosis of hematologic malignancy or aplastic anemia within the past 15 years at the Division of Pediatric Hematology/Oncology at Vanderbilt University - Previously treated with dapsone as prophylaxis for pneumocystis carinii - May or may not have symptomatic methemoglobinemia PATIENT CHARACTERISTICS: - Not specified PRIOR CONCURRENT THERAPY: - Not specified
|Official title||Dapsone Induced Methemoglobinemia Study (DIMS)|
|Principal investigator||Adam J. Esbenshade, MD|
|Description||OBJECTIVES: Primary - 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. Secondary - 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.|
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