Tumor DNA and MRI/CT Scan Findings in Patients With Grade III or Grade IV Malignant Glioma

Johns Hopkins Medicine

Status: Completed

Conditions: High Grade Glioma

Treatments: Procedure: polymerase chain reaction; Procedure: computed tomography; Procedure: DNA methylation analysis; Procedure: magnetic resonance imaging

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00897611

U01CA062475 (U.S. NIH Grant/Contract)

NABTT-0402

NABTT-0402 CDR0000462562

Details and patient eligibility

About

RATIONALE: Studying levels of tumor DNA in the samples of blood from patients with cancer may help doctors find out whether the cancer has grown and how much.

PURPOSE: This laboratory study is comparing levels of tumor DNA with MRI and CT scan findings to measure cancer growth in patients with grade III or grade IV malignant glioma.

Full description

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.

Enrollment: 42 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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