- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00006342
Genetic Study in Patients Receiving Treatment for Hodgkin's Disease or Childhood Brain Tumor
Analyses of Mutations Associated With Secondary Leukemia or Non-Hodgkin's Lymphoma in Patients Treated for Hodgkin's Disease or Childhood Brain Tumors
RATIONALE: Determination of genetic markers for leukemia or non-Hodgkin's lymphoma that is secondary to Hodgkin's disease and childhood brain tumors may help doctors to identify patients who are at risk for these cancers.
PURPOSE: Clinical trial to determine the presence of certain genes in patients who are receiving treatment for Hodgkin's disease or childhood brain tumors.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
OBJECTIVES: I. Determine the frequency of chromosome 3, 11, and 21 aberrations in peripheral blood lymphocytes (PBL) specifically associated with acute myelogenous leukemia in patients with adult or pediatric Hodgkin's disease treated with radiotherapy and/or chemotherapy. II. Determine the frequency of these aberrations in patients with pediatric central nervous system tumors treated with radiotherapy and/or chemotherapy. III. Determine the glutathione-S-transferase allotype, associated with human toxicological response to carcinogen exposure, for these patients. IV. Determine the frequency of t(14;18) gene rearrangement, associated with deregulation of the bcl-2 proto-oncogene in non-Hodgkin's lymphoma, in PBL of these patients.
OUTLINE: An extra tube of blood is collected before, every 4 weeks during, and every 3 months after radiotherapy and/or chemotherapy. DNA is isolated from the blood sample and the GSTM1, GSTT1, and various cytochrome P (CYP) 450 genotypes are determined by polymerase chain reaction (PCR). Mononuclear leukocytes are analyzed for chromosome aberrations on chromosome numbers 3, 11, and 21. Pretreatment karyotype and frequency of translocations are determined for each patient. Peripheral blood lymphocyte DNA is also examined for t(14;18) gene rearrangements.
PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study within 2 years.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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North Carolina
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Durham, North Carolina, United States, 27710
- Duke Comprehensive Cancer Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
Genders Eligible for Study
Description
DISEASE CHARACTERISTICS: Diagnosis of Hodgkin's disease Adult or child OR Diagnosis of primary central nervous system (CNS) malignancy 16 and under Medulloblastoma Ependymoma Brain stem glioma Astrocytoma Primitive neuroectodermal tumor (PNET) Proposed therapy must include external beam radiotherapy and/or chemotherapy
PATIENT CHARACTERISTICS: Age: See Disease Characteristics Any age Performance status: Not specified Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics Surgery: Not specified
Study Plan
How is the study designed?
Design Details
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Chair: Edward C. Halperin, MD, Duke Cancer Institute
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
- untreated childhood brain stem glioma
- childhood high-grade cerebral astrocytoma
- recurrent adult Hodgkin lymphoma
- recurrent/refractory childhood Hodgkin lymphoma
- stage III adult Hodgkin lymphoma
- stage IV adult Hodgkin lymphoma
- untreated childhood medulloblastoma
- untreated childhood cerebellar astrocytoma
- childhood infratentorial ependymoma
- newly diagnosed childhood ependymoma
- stage IV childhood Hodgkin lymphoma
- stage III childhood Hodgkin lymphoma
- stage I adult Hodgkin lymphoma
- stage II adult Hodgkin lymphoma
- stage I childhood Hodgkin lymphoma
- stage II childhood Hodgkin lymphoma
- childhood supratentorial ependymoma
- recurrent childhood supratentorial primitive neuroectodermal tumor
- recurrent childhood cerebellar astrocytoma
- recurrent childhood cerebral astrocytoma
- recurrent childhood ependymoma
- recurrent childhood brain stem glioma
- recurrent childhood medulloblastoma
- childhood low-grade cerebral astrocytoma
- untreated childhood supratentorial primitive neuroectodermal tumor
Additional Relevant MeSH Terms
Other Study ID Numbers
- CDR0000067681
- DUMC-0113-99-1R2
- DUMC-IRB-086-97-1
- NCI-G00-1840
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