Genetic Study in Patients Receiving Treatment for Hodgkin's Disease or Childhood Brain Tumor

NCT ID: NCT00006342

Last Updated: 2015-10-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

19 participants

Study Classification

OBSERVATIONAL

Study Start Date

1997-01-31

Study Completion Date

2001-01-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Brain and Central Nervous System Tumors Lymphoma

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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chromosomal translocation analysis

Intervention Type GENETIC

gene rearrangement analysis

Intervention Type GENETIC

mutation analysis

Intervention Type GENETIC

Eligibility Criteria

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Inclusion Criteria

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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Duke University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Edward C. Halperin, MD

Role: STUDY_CHAIR

Duke Cancer Institute

Locations

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Duke Comprehensive Cancer Center

Durham, North Carolina, United States

Site Status

Countries

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United States

Other Identifiers

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DUMC-0113-99-1R2

Identifier Type: -

Identifier Source: secondary_id

DUMC-IRB-086-97-1

Identifier Type: -

Identifier Source: secondary_id

NCI-G00-1840

Identifier Type: -

Identifier Source: secondary_id

CDR0000067681

Identifier Type: -

Identifier Source: org_study_id

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