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

This study has been completed.
Sponsor:
Collaborators:
National Cancer Institute (NCI)
North American Brain Tumor Consortium
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00897611
First received: May 9, 2009
Last updated: November 29, 2012
Last verified: November 2012
History of Changes
  Purpose

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.


Condition Intervention
High Grade Glioma
 Procedure: DNA methylation analysis
Procedure: polymerase chain reaction
Procedure: computed tomography
Procedure: magnetic resonance imaging

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Identification of Hypermethylated Serum Tumor DNA in High Grade Glioma Patients and Correlation With Magnetic Resonance Imaging Findings

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Sidney Kimmel Comprehensive Cancer Center:

Primary Outcome Measures:
  • Total plasma glioma-specific DNA concentration [ Time Frame: every 2 months until death ] [ Designated as safety issue: No ]
  • Tumor size [ Time Frame: every 2 months until death ] [ Designated as safety issue: No ]

Enrollment: 42
Study Start Date: April 2005
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: DNA methylation analysis
    Other Name: blood collection
    Procedure: polymerase chain reaction
    Other Name: blood collection
    Procedure: computed tomography
    Other Name: CT scan
    Procedure: magnetic resonance imaging
    Other Name: MRI scan
Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00897611

Sponsors and Collaborators
Sidney Kimmel Comprehensive Cancer Center
National Cancer Institute (NCI)
North American Brain Tumor Consortium
Investigators
Study Chair: Stuart A. Grossman, MD Sidney Kimmel Comprehensive Cancer Center
Principal Investigator: Kyle Weaver, MD Vanderbilt-Ingram Cancer Center
  More Information

Additional Information:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Sidney Kimmel Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00897611     History of Changes
Other Study ID Numbers: NABTT-0402 CDR0000462562, U01CA062475, NABTT-0402
Study First Received: May 9, 2009
Last Updated: November 29, 2012
Health Authority: United States: Federal Government
United States: Institutional Review Board

Keywords provided by Sidney Kimmel Comprehensive Cancer Center:
adult anaplastic astrocytoma
adult anaplastic oligodendroglioma
adult giant cell glioblastoma
 recurrent adult brain tumor
adult glioblastoma
adult gliosarcoma

Additional relevant MeSH terms:
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
 Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue

ClinicalTrials.gov processed this record on June 17, 2013