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