| Conditions: |
|
Brain and Central Nervous System Tumors |
| 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.
|
| Study Summary: |
|
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.
|
| 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
|
| NCT ID: |
|
NCT00756106 |
| Primary Contact: |
|
Study Chair
A. Gregory Sorensen, MD
Massachusetts General Hospital
|
| Backup Contact: |
|
N/A |
| Location Contact: |
|
Boston, Massachusetts 02114
United States
Clinical Trials Office - Massachusetts General Hospital
Phone: 877-726-5130
Site Status: Recruiting |