MRI Scans in Evaluating the Effects of Radiation Therapy and Chemotherapy in Patients With Newly Diagnosed Glioblastoma Multiforme or Anaplastic Glioma

This study has been terminated.

(Funding ended)

Sponsor:

Collaborator:

National Cancer Institute (NCI)

Information provided by (Responsible Party):

Elizabeth R. Gerstner, MD, Massachusetts General Hospital

ClinicalTrials.gov Identifier:

NCT00756106

First received: September 18, 2008

Last updated: January 12, 2012

Last verified: January 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

September 18, 2008

Last Updated Date

January 12, 2012

Start Date ^ICMJE

July 2008

Primary Completion Date

September 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Relative cerebral blood volume/flow, mean transit time, and mean vessel diameter as measured by perfusion-weighted MRI before, during, and after chemoradiotherapy [ Time Frame: months ] [ Designated as safety issue: No ]
Permeability-surface area product before, during, and after chemoradiotherapy [ Time Frame: months ] [ Designated as safety issue: No ]
Full water self-diffusion tensor before, during, and after chemoradiotherapy [ Time Frame: months ] [ Designated as safety issue: No ]
Tensor fractional anisotropy before, during, and after chemoradiotherapy [ Time Frame: months ] [ Designated as safety issue: No ]
Relative regional concentrations of choline, N-acetyl-asparate, and myoinositol as measured by magnetic resonance spectroscopy before, during, and after chemoradiotherapy to interrogate cell membrane turnover, neuronal integrity, and glial reactions [ Time Frame: months ] [ Designated as safety issue: No ]
Affects of a short period of 100% oxygen inhalation on imaging of tumor and surrounding tissue regions of interest, specifically cerebral blood volume changes in each area as compared to room air [ Time Frame: months ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Relative cerebral blood volume/flow, mean transit time, and mean vessel diameter as measured by perfusion-weighted MRI before, during, and after chemoradiotherapy [ Designated as safety issue: No ]
Permeability-surface area product before, during, and after chemoradiotherapy [ Designated as safety issue: No ]
Full water self-diffusion tensor before, during, and after chemoradiotherapy [ Designated as safety issue: No ]
Tensor fractional anisotropy before, during, and after chemoradiotherapy [ Designated as safety issue: No ]
Relative regional concentrations of choline, N-acetyl-asparate, and myoinositol as measured by magnetic resonance spectroscopy before, during, and after chemoradiotherapy to interrogate cell membrane turnover, neuronal integrity, and glial reactions [ Designated as safety issue: No ]
Affects of a short period of 100% oxygen inhalation on imaging of tumor and surrounding tissue regions of interest, specifically cerebral blood volume changes in each area as compared to room air [ Designated as safety issue: No ]

Change History

Complete list of historical versions of study NCT00756106 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Correlation between imaging changes, molecular markers, and clinical outcome [ Time Frame: months ] [ Designated as safety issue: No ]
Correlation between blood and urine biomarkers and tumor expression of these markers [ Time Frame: months ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Correlation between imaging changes, molecular markers, and clinical outcome [ Designated as safety issue: No ]
Correlation between blood and urine biomarkers and tumor expression of these markers [ Designated as safety issue: No ]

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

MRI Scans in Evaluating the Effects of Radiation Therapy and Chemotherapy in Patients With Newly Diagnosed Glioblastoma Multiforme or Anaplastic Glioma

Official Title ^ICMJE

Quantitative Assessment of the Early and Late Effects of Radiation and Chemotherapy on Glioblastoma Using Multiple MRI Techniques

Brief Summary

RATIONALE: Diagnostic procedures, such as MRI, may help in learning how well radiation therapy and chemotherapy work in killing tumor cells and allow doctors to plan better treatment.

PURPOSE: This clinical trial is studying MRI scans to see how well they evaluate the effects of radiation therapy and chemotherapy in patients with newly diagnosed glioblastoma multiforme or anaplastic glioma.

Detailed Description

OBJECTIVES:

Primary

To quantitatively compare the relative cerebral blood volume/flow, mean transit time, and mean vessel diameter as measured by perfusion-weighted MRI before, during, and after chemoradiotherapy in patients with newly diagnosed glioblastoma multiforme.
To measure the permeability-surface area product on a voxel-by-voxel basis before, during, and after chemoradiotherapy in these patients.
To measure the full water self-diffusion tensor on a voxel-by-voxel basis before, during, and after chemoradiotherapy in these patients.
To compare the tensor fractional anisotropy before, during, and after chemoradiotherapy in these patients.
To compare the relative regional concentrations of choline, N-acetyl-asparate, and myoinositol as measured by magnetic resonance spectroscopy before, during, and after chemoradiotherapy to interrogate cell membrane turnover, neuronal integrity, and glial reactions.
To test the affects of a short period of 100% oxygen inhalation on imaging of tumor and surrounding tissue regions of interest, specifically cerebral blood volume changes in each area as compared to room air.

Secondary

To collect blood and urine samples for correlation analysis between imaging changes, molecular markers (including genetic markers), and clinical outcome of glioblastoma multiforme (phenotypic information).
To correlate blood and urine biomarkers and blood genetic markers with tumor expression of these markers.

OUTLINE: Patients undergo radiotherapy once daily 5 days a week for 6 weeks. Patients also receive oral temozolomide once daily 7 days a week during radiotherapy. After completion of chemoradiotherapy, patients receive oral temozolomide once daily for 5 days. Treatment with temozolomide repeats every 28 days in the absence of disease progression or unacceptable toxicity.

Patients undergo MRI, including perfusion- and diffusion-weighted MRI, diffusion tensor imaging, and magnetic resonance spectroscopy prior to initiation of chemoradiotherapy, once weekly during chemoradiotherapy, and then monthly until tumor progression or until completion of 6 courses of post chemoradiotherapy.

After completion of study treatment, patients are followed annually.

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic

Condition ^ICMJE

Brain and Central Nervous System Tumors

Intervention ^ICMJE

Drug: temozolomide
chemotherapy
Other: imaging biomarker analysis
MRI

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Enrollment ^ICMJE

Completion Date

Not Provided

Primary Completion Date

September 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

DISEASE CHARACTERISTICS:

Newly diagnosed anaplastic glioma (WHO grade III) or glioblastoma multiforme (WHO grade IV)
Measurable disease
- Residual tumor size after surgery ≥ 1 cm in one dimension
Planning to undergo standard chemoradiotherapy with temozolomide

PATIENT CHARACTERISTICS:

Glomerular filtration rate ≥ 60 mL/min
Mini Mental Status Exam score > 15
Sufficiently competent to give informed consent
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective barrier contraception during and for 2 months after completion of study treatment
No contraindication to MRI or to use of the contrast agent gadolinium, including any of the following:
- Claustrophobia
- Metallic objects or implanted medical devices (e.g., cardiac pacemaker, aneurysm clips, surgical clips, prostheses, artificial hearts, valves with steel parts, metal fragments, shrapnel, tattoos near the eye, or steel implants)
- Sickle cell disease
- Renal failure
- High risk for kidney disease (e.g., age > 60 years, diabetes, or history of systemic lupus erythematosus or multiple myeloma)
No known history of chronic obstructive pulmonary disease or emphysema
No other co-existing condition that, in the judgement of the investigator, may increase risk to the patient

PRIOR CONCURRENT THERAPY:

See Disease Characteristics
Non-VEGF investigational agent allowed
No concurrent chemotherapy (other than temozolomide)
No concurrent electron, proton, particle, or implant radiotherapy
No concurrent stereotactic radiosurgery
No concurrent anti-VEGF anti-tumor agents

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00756106

Other Study ID Numbers ^ICMJE

CDR0000600751, MGH-07-292

Has Data Monitoring Committee

Yes

Responsible Party

Elizabeth R. Gerstner, MD, Massachusetts General Hospital

Study Sponsor ^ICMJE

Massachusetts General Hospital

Collaborators ^ICMJE

National Cancer Institute (NCI)

Investigators ^ICMJE

Principal Investigator:

Elizabeth Gerstner, MD

Massachusetts General Hospital

Information Provided By

Massachusetts General Hospital

Verification Date

January 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top