CClinicalTrials.gg
CompletedNCT00006342Updated Oct 15, 2015

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

An observational study in Brain and Central Nervous System Tumors and Lymphoma, sponsored by Duke University. Completed at 1 site in United States. Per ClinicalTrials.gov, last updated 2015-10-15.

Sponsored by Duke University · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
19
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Brain and Central Nervous System Tumors
  • Lymphoma

Keywords

  • 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
03

In context

Lymphoma

5,578 studies on the registry are indexed under Lymphoma; 825 are open to participants now.

This study's enrollment of 19 is below the median of 136 across 625 observational studies indexed under Lymphoma.

Browse Lymphoma studies →

Lead sponsor

Duke University is the lead sponsor of 2,025 studies on the registry; 275 are open to participants now.

Of its 194 completed or terminated interventional studies of FDA-regulated products, 159 (82%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility 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

05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
19 participants (actual)
Patient registry
No

Interventions

  • Geneticchromosomal translocation analysis
  • Geneticgene rearrangement analysis
  • Geneticmutation analysis
06

Study locations

1 site
  • Duke Comprehensive Cancer Center
    Durham, North Carolina 27710, United States
07

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 15, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
08

Registry details

Key details

Study ID
NCT00006342
Lead sponsor
Duke University
Collaborators
National Cancer Institute (NCI)
Responsible party
Sponsor
First posted
May 4, 2004
Start date
Jan 1997
Primary completion
Sep 2000
Completion
Jan 2001
Last update
Oct 15, 2015

Study contacts

Edward C. Halperin, MD
study chair · Duke Cancer Institute
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2013. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion