Methemoglobinemia in Patients With Childhood Hematologic Cancer or Aplastic Anemia Treated With Dapsone
Information source: National Cancer Institute (NCI)
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Leukemia; Lymphoma; Methemoglobinemia; Nonmalignant Neoplasm
Intervention: polymorphism analysis (Genetic); laboratory biomarker analysis (Other); medical chart review (Other); assessment of therapy complications (Procedure)
Phase: Phase 1
Status: Active, not recruiting
Sponsored by: Vanderbilt-Ingram Cancer Center Official(s) and/or principal investigator(s): Adam J. Esbenshade, MD, Principal Investigator, Affiliation: Vanderbilt-Ingram Cancer Center Kathleen M. Von Wahlde, Affiliation: Vanderbilt-Ingram Cancer Center
Summary
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.
Clinical Details
Official title: Dapsone Induced Methemoglobinemia Study (DIMS)
Study design: N/A
Primary outcome: Age, sex, and body mass index as host-related risk factors for developing symptomatic methemoglobinemiaCytochrome b5 reductase levels
Detailed 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.
Eligibility
Minimum age: N/A.
Maximum age: 22 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Vanderbilt-Ingram Cancer Center, Nashville, Tennessee 37232-6838, United States
Vanderbilt-Ingram Cancer Center - Cool Springs, Nashville, Tennessee 37064, United States
Additional Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Starting date: June 2009
Last updated: May 28, 2010
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