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:
Information provided by (Responsible Party):
Elizabeth R. Gerstner, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00756106
First received: September 18, 2008
Last updated: February 6, 2014
Last verified: February 2014

September 18, 2008
February 6, 2014
July 2008
September 2011   (final data collection date for primary outcome measure)
  • 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 ]
  • 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 ]
Complete list of historical versions of study NCT00756106 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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 ]
Not Provided
Not Provided
 
MRI Scans in Evaluating the Effects of Radiation Therapy and Chemotherapy in Patients With Newly Diagnosed Glioblastoma Multiforme or Anaplastic Glioma
Quantitative Assessment of the Early and Late Effects of Radiation and Chemotherapy on Glioblastoma Using Multiple MRI Techniques

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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Newly diagnosed GBM

Brain and Central Nervous System Tumors
  • Drug: temozolomide
    chemotherapy
  • Other: imaging biomarker analysis
    MRI
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
16
Not Provided
September 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00756106
CDR0000600751, MGH-07-292
Yes
Elizabeth R. Gerstner, MD, Massachusetts General Hospital
Massachusetts General Hospital
National Cancer Institute (NCI)
Principal Investigator: Elizabeth Gerstner, MD Massachusetts General Hospital
Massachusetts General Hospital
February 2014

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