Methemoglobinemia in Patients With Childhood Hematologic Cancer or Aplastic Anemia Treated With Dapsone
This study is ongoing, but not recruiting participants.
Sponsor:
Vanderbilt-Ingram Cancer Center
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
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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:
Genetics Home Reference related topics:
methemoglobinemia, beta-globin type
Drug Information available for:
Dapsone
U.S. FDA Resources
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) |
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
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:
|
Anemia, Aplastic Neoplasms Leukemia Lymphoma Methemoglobinemia Anemia Hematologic Diseases Bone Marrow Diseases Neoplasms by Histologic Type Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases |
Dapsone Antimalarials Antiprotozoal Agents Antiparasitic Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Folic Acid Antagonists Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Leprostatic Agents Anti-Bacterial Agents |
ClinicalTrials.gov processed this record on May 19, 2013