Clinical Trial Finder

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

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.

Arms

Experimental: Temozolomide and Radiation Therapy

Interventions

Drug: - temozolomide

Temozolomide is administered according to standard of care practice guidelines. Dosing may be modified at the discretion of the treating investigator.

Other: - Imaging biomarker analysis

MRI

Radiation: - Photon Radiation Therapy

Radiation is administered to the tumor plus edema with a 1-2 centimeter margin for a total dose of 60 Gy in 30 fractions.