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| Sponsors and Collaborators: |
Duke University National Cancer Institute (NCI) |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00006342 |
Purpose
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.
| Condition | Intervention |
|---|---|
|
Brain and Central Nervous System Tumors Lymphoma |
Genetic: chromosomal translocation analysis Genetic: gene rearrangement analysis Genetic: mutation analysis |
| Study Type: | Observational |
| Official Title: | Analyses of Mutations Associated With Secondary Leukemia or Non-Hodgkin's Lymphoma in Patients Treated for Hodgin's Disease or Childhood Brain Tumors |
| Study Start Date: | February 2000 |
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 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.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS: Diagnosis of Hodgkin's disease Adult or child OR Diagnosis of primary 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
Contacts and Locations| United States, North Carolina | |
| Duke Comprehensive Cancer Center | |
| Durham, North Carolina, United States, 27710 | |
| Study Chair: | Edward C. Halperin, MD | Duke University |
More Information
| Study ID Numbers: | CDR0000067681, DUMC-0113-99-1R2, DUMC-IRB-086-97-1, NCI-G00-1840 |
| Study First Received: | October 4, 2000 |
| Last Updated: | February 6, 2009 |
| ClinicalTrials.gov Identifier: | NCT00006342 History of Changes |
| Health Authority: | United States: Federal Government |
|
stage I adult Hodgkin lymphoma stage II adult Hodgkin lymphoma stage III adult Hodgkin lymphoma stage IV adult Hodgkin lymphoma recurrent adult Hodgkin lymphoma childhood infratentorial ependymoma childhood low-grade cerebral astrocytoma childhood supratentorial ependymoma stage II childhood Hodgkin lymphoma stage I childhood Hodgkin lymphoma stage III childhood Hodgkin lymphoma stage IV childhood Hodgkin lymphoma recurrent/refractory childhood Hodgkin lymphoma |
childhood high-grade cerebral astrocytoma untreated childhood brain stem glioma recurrent childhood brain stem glioma untreated childhood supratentorial primitive neuroectodermal tumor recurrent childhood supratentorial primitive neuroectodermal tumor untreated childhood cerebellar astrocytoma recurrent childhood cerebellar astrocytoma recurrent childhood cerebral astrocytoma untreated childhood medulloblastoma recurrent childhood medulloblastoma newly diagnosed childhood ependymoma recurrent childhood ependymoma |
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Neuroectodermal Tumors, Primitive Hodgkin Lymphoma, Childhood Central Nervous System Neoplasms Brain Diseases Ependymoma Lymphoma, Small Cleaved-cell, Diffuse Leukemia Neoplasm Metastasis Neuroepithelioma Glioma Hodgkin Disease Lymphoma Nervous System Neoplasms Immunoproliferative Disorders |
Astrocytoma Hodgkin Lymphoma, Adult Brain Tumor, Childhood Central Nervous System Diseases Hodgkin's Disease Recurrence Neuroectodermal Tumors Brain Neoplasms Lymphatic Diseases Brain Stem Glioma, Childhood Medulloblastoma Lymphoma, Non-Hodgkin Lymphoproliferative Disorders |
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Neoplasms by Histologic Type Immunoproliferative Disorders Immune System Diseases Nervous System Diseases Central Nervous System Diseases Central Nervous System Neoplasms Brain Diseases |
Brain Neoplasms Lymphatic Diseases Neoplasms Neoplasms by Site Lymphoproliferative Disorders Lymphoma Nervous System Neoplasms |
