Overview

MRI Scans in Evaluating the Effects of Radiation Therapy and Chemotherapy in Patients With Newly Diagnosed Glioblastoma Multiforme or Anaplastic Glioma

Status:
Terminated
Trial end date:
2012-02-01
Target enrollment:
0
Participant gender:
All
Summary
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.
Phase:
N/A
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Massachusetts General Hospital
Collaborator:
National Cancer Institute (NCI)
Treatments:
Temozolomide
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