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Identification of Hypermethylated Serum Tumor DNA in High Grade Glioma Patients and Correlation With Magnetic Resonance Imaging Findings


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18 Years
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Not Enrolling
Both
High Grade Glioma

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Trial Information

Identification of Hypermethylated Serum Tumor DNA in High Grade Glioma Patients and Correlation With Magnetic Resonance Imaging Findings


OBJECTIVES:

- Correlate changes in the level of serum tumor-specific DNA over time with changes in
brain tumor size as measured by serial MRI or CT scans in patients with grade III-IV
malignant gliomas.

OUTLINE: This is a multicenter study.

Blood samples are collected from patients at baseline and every 2 months thereafter. Tumor
and nontumor plasma is extracted. Plasma samples are analyzed by polymerase chain reaction
(PCR) to assess the p16_ink4a, p73, and O ^6-MGMT gene promoter methylation profile.
Quantitative realtime PCR is performed on samples with tumor-specific DNA to determine the
plasma concentrations of each methylated tumor-specific gene and the total plasma
tumor-specific DNA concentration. Patients also undergo MRI or CT scans every 2 months.

PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed malignant brain tumor

- One of the following grade III or IV supratentorial gliomas:

- Anaplastic astrocytoma

- Anaplastic oligodendroglioma

- Glioblastoma multiforme

- Newly diagnosed or recurrent disease

- Planning to undergo anticancer therapy on a New Approaches to Brain Tumor Therapy
(NABTT) Consortium clinical trial

PATIENT CHARACTERISTICS:

- Karnofsky performance status 60-100%

PRIOR CONCURRENT THERAPY:

- See Disease Characteristics

Type of Study:

Interventional

Study Design:

Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label

Outcome Measure:

Total plasma glioma-specific DNA concentration

Outcome Time Frame:

every 2 months until death

Safety Issue:

No

Principal Investigator

Stuart A. Grossman, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Sidney Kimmel Comprehensive Cancer Center

Authority:

United States: Federal Government

Study ID:

NABTT-0402 CDR0000462562

NCT ID:

NCT00897611

Start Date:

April 2005

Completion Date:

Related Keywords:

  • High Grade Glioma
  • adult anaplastic astrocytoma
  • adult anaplastic oligodendroglioma
  • adult giant cell glioblastoma
  • recurrent adult brain tumor
  • adult glioblastoma
  • adult gliosarcoma
  • Glioma

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