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


N/A
18 Years
N/A
Not Enrolling
Both
Brain and Central Nervous System Tumors

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Trial Information

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


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.

Inclusion Criteria


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

Type of Study:

Interventional

Study Design:

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

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

Outcome Time Frame:

months

Safety Issue:

No

Principal Investigator

Elizabeth Gerstner, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Massachusetts General Hospital

Authority:

United States: NCI

Study ID:

CDR0000600751

NCT ID:

NCT00756106

Start Date:

July 2008

Completion Date:

Related Keywords:

  • Brain and Central Nervous System Tumors
  • adult glioblastoma
  • adult giant cell glioblastoma
  • adult gliosarcoma
  • adult anaplastic astrocytoma
  • adult anaplastic ependymoma
  • adult anaplastic oligodendroglioma
  • adult mixed glioma
  • Glioblastoma
  • Nervous System Neoplasms
  • Central Nervous System Neoplasms

Name

Location

Massachusetts General HospitalBoston, Massachusetts  02114-2617