A Phase II, Investigator-Initiated Study of Imipramine Hydrochloride and Lomustine in Recurrent Glioblastoma
This study is designed as a single center, prospective, open label, single-arm therapeutic trial with both surgical and non-surgical cohorts.
• The subject is at least 18 years of age
• The subject has the ability to understand the purposes and risks of the study and to have signed a written informed consent form approved by the investigator's IRB/Ethics Committee
• The subject has histologically confirmed glioblastoma
• The subject has progression following standard combined modality treatment with radiation and temozolomide chemotherapy
• The subject has an ECOG (Eastern Cooperative Oncology Group) performance status ≤ 2
• The subject has a life expectancy of at least 3 months
• The subject has acceptable liver function:
• Bilirubin ≤ 1.5 times upper limit of normal
• AST (aspartate aminotransferase) (SGOT) and ALT (alanine transaminase 0 (SGPT) ≤ 3.0 times upper limit of normal (ULN)
• The subject has acceptable renal function:
• Serum creatinine ≤ULN
• The subject has acceptable hematologic status (without hematologic support):
• ANC (absolute neutrophil count) ≥1500 cells/uL
• Platelet count ≥100,000/uL
• Hemoglobin ≥9.0 g/dL
• All women of childbearing potential (not surgically sterilized or at least 1 year post-menopausal) must have a negative serum pregnancy test. Additionally, male and female subjects must agree to use effective means of contraception (surgical sterilization or the use or barrier contraception with either a condom or diaphragm in conjunction with spermicidal gel or an IUD) with their partner from entry into the study through 6 months after the last dose.