Phase I Study of AZD1775 (MK-1775) with Radiation and Temozolomide in Patients with Newly Diagnosed Glioblastoma and Evaluation of Intratumoral Drug Distribution in Patients with Recurrent Glioblastoma
Johns Hopkins Kimmel Cancer Center in Baltimore
This study is for patients with recurrent glioblastoma requiring surgery. The purpose of this cohort is to obtain more safety data for AZD1775 (MK-1775) given concurrently with radiation therapy, and with AZD1775 (MK-1775) with adjuvant TMZ (chemotherapy). Blood and tissue samples will yield data to continue research on the effectiveness and safety of anti-tumor medication concurrent with current standard of care practices of radiation or chemotherapy.
Patients must be 18 years of age or older. Patients must have a Karnofsky Performance Status greater than 60% (i.e. the patient must be able to care for himself/herself with occasional help from others).Absolute neutrophil count greater than 1,500/mcLPlatelets greater than 100,000/mcLHemoglobin greater than 9 g/dLTotal bilirubin within normal institutional limitsAST (SGOT)/ALT (SGPT)3 Ã? institutional upper limit of normalCreatinine within normal institutional limits APTTâ?¤ 1.5 x institutional upper limit of normalPatients must have no concurrent malignancy except curatively treated basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix, breast, or bladder. Patients with prior malignancies must be disease-free for five years.Patients must be maintained on a stable corticosteroid regimen (no increase for 5 days) prior to the start of treatment.Patients must be able to swallow whole capsules.
12 patients will be enrolled and treated with AZD1775 (MK-1775) for 4 days prior to surgery, and the day of surgery.After surgery, patients will have three options for further treatment which they will discuss with their doctor.Radiation and AZD1775, AZD1775 and chemotherapy, or to discontinue study.
12/15/2017 05:03 AM