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
Phase phase 1
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

Primary Outcomes

Age, sex, and body mass index as host-related risk factors for developing symptomatic methemoglobinemia
time frame:
Cytochrome b5 reductase levels
time frame:

Eligibility Criteria

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

Additional Information

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.
Trial information was received from ClinicalTrials.gov and was last updated in May 2010.
Information provided to ClinicalTrials.gov by National Cancer Institute (NCI).