MRI Scans in Evaluating the Effects of Radiation Therapy and Chemotherapy in Patients With Newly Diagnosed Glioblastoma Multiforme - Full Text View

Sponsors and Collaborators:	Massachusetts General Hospital National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00756106

Purpose

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.

Condition	Intervention
Brain and Central Nervous System Tumors	Drug: temozolomide Other: imaging biomarker analysis Procedure: contrast-enhanced magnetic resonance imaging Procedure: diffusion tensor imaging Procedure: diffusion-weighted magnetic resonance imaging Procedure: magnetic resonance spectroscopic imaging Radiation: radiation therapy

MedlinePlus related topics: Cancer MRI Scans Nuclear Scans Radiation Therapy

Drug Information available for: Temozolomide

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Diagnostic
Official Title:	Quantitative Assessment of the Early and Late Effects of Radiation and Chemotherapy on Glioblastoma Using Multiple MRI Techniques

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	30
Study Start Date:	July 2008
Estimated Primary Completion Date:	May 2009 (Final data collection date for primary outcome measure)

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

Newly diagnosed glioblastoma multiforme
- WHO grade IV tumor
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
No concurrent chemotherapy (other than temozolomide)
No concurrent electron, proton, particle, or implant radiotherapy
No concurrent stereotactic radiosurgery
No concurrent investigational anti-tumor agents

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00756106

Locations

United States, Massachusetts
Massachusetts General Hospital	Recruiting
Boston, Massachusetts, United States, 02114
Contact: Clinical Trials Office - Massachusetts General Hospital 877-726-5130

Sponsors and Collaborators

Massachusetts General Hospital

National Cancer Institute (NCI)

Investigators

Study Chair:	A. Gregory Sorensen, MD	Dana-Farber Cancer Institute
Investigator:	Tracy Batchelor, MD, MPH	Massachusetts General Hospital

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

Study ID Numbers:	CDR0000600751, MGH-07-292
Study First Received:	September 18, 2008
Last Updated:	February 6, 2009
ClinicalTrials.gov Identifier:	NCT00756106 History of Changes
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

adult glioblastoma
adult giant cell glioblastoma
adult gliosarcoma

Study placed in the following topic categories:

Glioblastoma
Astrocytoma
Central Nervous System Neoplasms
Temozolomide
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neuroepithelioma

Glioma
Glioblastoma Multiforme
Antineoplastic Agents, Alkylating
Gliosarcoma
Alkylating Agents
Nervous System Neoplasms
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:

Glioblastoma
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Astrocytoma
Antineoplastic Agents
Nervous System Diseases
Neoplasms, Nerve Tissue
Central Nervous System Neoplasms
Temozolomide
Pharmacologic Actions
Neuroectodermal Tumors

Neoplasms
Neoplasms by Site
Therapeutic Uses
Neoplasms, Germ Cell and Embryonal
Antineoplastic Agents, Alkylating
Glioma
Neoplasms, Neuroepithelial
Alkylating Agents
Nervous System Neoplasms
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on May 07, 2009