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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00960050
First received: August 14, 2009
Last updated: May 28, 2010
Last verified: May 2010
  Purpose

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.


Condition Intervention Phase
Leukemia
Lymphoma
Methemoglobinemia
Nonmalignant Neoplasm
Genetic: polymorphism analysis
Other: laboratory biomarker analysis
Other: medical chart review
Procedure: assessment of therapy complications
Phase 1

Study Type: Observational
Official Title: Dapsone Induced Methemoglobinemia Study (DIMS)

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • 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 ]

Estimated Enrollment: 173
Study Start Date: June 2009
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
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

Ages Eligible for Study:   up to 22 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00960050

Locations
United States, Tennessee
Vanderbilt-Ingram Cancer Center - Cool Springs
Nashville, Tennessee, United States, 37064
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States, 37232-6838
Sponsors and Collaborators
Vanderbilt-Ingram Cancer Center
Investigators
Principal Investigator: Adam J. Esbenshade, MD Vanderbilt-Ingram Cancer Center
Investigator: Kathleen M. Von Wahlde Vanderbilt-Ingram Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Adam J. Esbenshade, Vanderbilt-Ingram Cancer Center
ClinicalTrials.gov Identifier: NCT00960050     History of Changes
Other Study ID Numbers: CDR0000651820, VU-VICC-PED-0937
Study First Received: August 14, 2009
Last Updated: May 28, 2010
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
methemoglobinemia
aplastic anemia
childhood acute lymphoblastic leukemia
childhood acute myeloid leukemia/other myeloid malignancies
childhood chronic myelogenous leukemia
juvenile myelomonocytic leukemia
childhood Hodgkin lymphoma
childhood large cell lymphoma
childhood lymphoblastic lymphoma
childhood small noncleaved cell lymphoma
childhood anaplastic large cell lymphoma
childhood diffuse large cell lymphoma
childhood grade III lymphomatoid granulomatosis
childhood immunoblastic large cell lymphoma
childhood nasal type extranodal NK/T-cell lymphoma
childhood myelodysplastic syndromes

Additional relevant MeSH terms:
Lymphoma
Leukemia
Methemoglobinemia
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Hematologic Diseases

ClinicalTrials.gov processed this record on September 29, 2014