This phase II trial studies the side effects and how well giving low-dose fractionated radiation therapy and temozolomide works in treating patients with anaplastic astrocytoma or glioblastoma multiforme that has returned after a period of improvement (recurrent). Radiation therapy uses high energy x-rays to kill tumor cells. Chemotherapy drugs, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy may make it easier for chemotherapy drugs to enter tumor cells and may work better when given with temozolomide in treating patients with recurrent anaplastic astrocytoma or glioblastoma multiforme.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT01466686.
PRIMARY OBJECTIVES:
I. To select a safe and tolerated dose schedule (i.e.: number of consecutive twice daily fractions) of low-dose fractionated radiation therapy (LDFRT) + temozolomide based on hematologic toxicity at one month following initiation of therapy. (Safety run-in)
II. To estimate the one year overall survival in patients treated with LDFRT + temozolomide for recurrent high grade glioma (HGG). (Phase II)
SECONDARY OBJECTIVES:
I. To estimate the acute and late radiation-associated neurologic toxicity of salvage LDFRT + temozolomide. (Safety run-in)
II. To estimate the 6 month progression free survival in patients treated with LDFRT plus temozolomide for recurrent HGG. (Phase II)
III. To estimate the rate of pseudoprogression in patients treated with LDFRT plus temozolomide for recurrent HGG. (Phase II)
IV. To characterize the chronologic sequence of pseudoprogression in patients treated with LDFRT plus temozolomide for recurrent HGG. (Phase II)
V. To estimate the hematologic toxicity of salvage LDFRT + temozolomide. (Phase II)
VI. To estimate the radiation-associated acute and long term neurologic toxicity of salvage LDFRT + temozolomide. (Phase II)
OUTLINE:
Patients receive temozolomide orally (PO) for 5 days. Patients also undergo low-dose fractionated radiation therapy twice daily (BID) five days a week in cycles 1-6 of temozolomide. Cycles with temozolomide repeat every 28 days for up to 1 year in the absence of disease progression.
After completion of study treatment, patients are followed up at 3, 6, and 12 months, and then periodically.
Lead OrganizationJohns Hopkins University/Sidney Kimmel Cancer Center
Principal InvestigatorKristin Janson Redmond