Study of Lenalidomide and XRT in Patients With Newly Diagnosed Glioblastoma Multiforme

Inclusion Criteria

• •Patients with histologically confirmed newly-diagnosed supratentorial glioblastoma multiforme (GBM) or gliosarcoma will be eligible for this protocol.
• •The patient must have recovered from the effects of surgery, post-operative infections and other complications before entry into the study.
• •Diagnosis will have been established by biopsy or resection no more than 28 days prior to registration.
• •If tumor resection or open biopsy was performed, cranial MRI or contrast CT must have been performed before and after surgery. Imaging within 96 h of surgery is preferred but not required.
• •If needle biopsy (stereotactic) was performed, gadolinium MRI or contrast CT within 14 days prior to registration is required. A post-operative scan is not required. The use of MRI rather than CT is preferred. The same type of scan, i.e., MRI or CT must be used throughout the period of protocol treatment for tumor measurement. Patients without measurable or assessable disease are eligible.
• •Patients receiving steroids must be on stable or decreasing doses for at least 5 days prior to entry.
• •Patients must have a plan to begin partial brain radiotherapy 4-7 days after beginning lenalidomide, and within 35 days of the surgical procedure that established the diagnosis.
• •Radiotherapy must be at the Radiation Oncology Department of the registered institution.
• •Patients must be willing to forego cytotoxic and non-cytotoxic drug therapy against the tumor while being treated with lenalidomide.
• •All patients must sign an informed consent indicating that they are aware of the investigational nature of this study.
• •Patients must be \> 18 years old, and with a life expectancy \> 8 weeks.
• •Patients must have a Karnofsky performance status of \> 60.
• •Patients must have adequate bone marrow, liver, and renal function.
• •Patients must be willing and able to comply with all study requirements
• •Patients must not have metastases below the tentorium or beyond the cranial vault.
• •Patients must not have a known diagnosis of HIV, active infectious hepatitis, or chronic hepatitis.
• •Patients must have no history of hypersensitivity or development of a desquamating rash while on thalidomide.
• •Patients must have no prior exposure to lenalidomide.
• •Previous or planned stereotactic radiosurgery or brachytherapy.