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

High Grade Glioma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00897611
• Other study ID #: NABTT-0402 CDR0000462562
• Secondary ID: U01CA062475NABTT
• Status: Completed
• Phase: N/A
• First received: May 9, 2009
• Last updated: November 29, 2012
• Start date: April 2005

Study information

• Verified date: November 2012
• Source: Sidney Kimmel Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal GovernmentUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. primary completion date: August 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Glioma
• High Grade Glioma

Intervention

Procedure:
• DNA methylation analysis

• polymerase chain reaction

• computed tomography

• magnetic resonance imaging

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Sidney Kimmel Comprehensive Cancer Center	National Cancer Institute (NCI), North American Brain Tumor Consortium

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total plasma glioma-specific DNA concentration		every 2 months until death	No
Primary	Tumor size		every 2 months until death	No