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

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

October 4, 2000

Last Updated Date

February 6, 2009

Start Date ^†

February 2000

Current Primary Outcome Measures ^†

Original Primary Outcome Measures ^†

Change History

Complete list of historical versions of study NCT00006342 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

Original Secondary Outcome Measures ^†

Descriptive Information

Brief Title ^†

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

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

Brief Summary

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

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.

Study Phase

Study Type ^†

Observational

Study Design ^†

Condition ^†

Brain and Central Nervous System Tumors
Lymphoma

Intervention ^†

Genetic: chromosomal translocation analysis
Genetic: gene rearrangement analysis
Genetic: mutation analysis

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Active, not recruiting

Enrollment ^†

Completion Date

Primary Completion Date

Eligibility Criteria ^†

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

Gender

Both

Ages

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

United States

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00006342

Responsible Party

Secondary IDs ^††

DUMC-0113-99-1R2, DUMC-IRB-086-97-1, NCI-G00-1840

Study Sponsor ^†

Duke University

Collaborators ^††

National Cancer Institute (NCI)

Investigators ^†

Study Chair:

Edward C. Halperin, MD

Duke University

Information Provided By

National Cancer Institute (NCI)

Verification Date

May 2001

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.