Methemoglobinemia in Patients With Childhood Hematologic Cancer or Aplastic Anemia Treated With Dapsone

Lymphoma Clinical Trial

Official title:

Dapsone Induced Methemoglobinemia Study (DIMS)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00960050
• Other study ID #: CDR0000651820
• Secondary ID: VU-VICC-PED-0937
• Status: Active, not recruiting
• Phase: Phase 1
• First received: August 14, 2009
• Last updated: May 28, 2010
• Start date: June 2009

Study information

• Verified date: May 2010
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 173
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 22 Years

Eligibility

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

Study Design

N/A

Related Conditions & MeSH terms

• Leukemia
• Lymphoma
• Methemoglobinemia
• Nonmalignant Neoplasm

Intervention

Genetic:
• polymorphism analysis

Other:
• laboratory biomarker analysis

• medical chart review

Procedure:
• assessment of therapy complications

Locations

Country	Name	City	State
United States	Vanderbilt-Ingram Cancer Center	Nashville	Tennessee
United States	Vanderbilt-Ingram Cancer Center - Cool Springs	Nashville	Tennessee

Sponsors (2)

Lead Sponsor	Collaborator
Vanderbilt-Ingram Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Age, sex, and body mass index as host-related risk factors for developing symptomatic methemoglobinemia			No
Primary	Cytochrome b5 reductase levels			No