Safety and Efficacy Study of Panzem NCD to Treat Glioblastoma
Recurrent Glioblastoma Multiforme
About this trial
This is an interventional treatment trial for Recurrent Glioblastoma Multiforme
Eligibility Criteria
Inclusion Criteria: Histologically confirmed diagnosis of a 1st or 2nd recurrent/progressive primary WHO grade IV malignant glioma (glioblastoma multiforme or gliosarcoma). 18 years or older An interval of at least 2 weeks between prior surgical resection or any major surgery or 4 weeks between prior radiotherapy or chemotherapy (except nitrosoureas which require 6 weeks) Karnofsky performance score equal to or greater than 70% Hematocrit greater than 29%, absolute neutrophil count greater than 1,500 cells/micro liters, platelets greater than 100,000 cells/ micro liters Serum creatinine less than 1.5 X upper limit of normal (ULN), serum SGOT less than 2.5 X ULN; and bilirubin less than 1.5 times ULN Signed informed consent form and authorization for use and disclosure of protected health information approved by the IRB prior to patient entry Agree to use effective contraceptive methods Exclusion Criteria: Current, active systemic bleeding or excessive risk of bleeding Be pregnant or lactating; not employing effective birth control Concurrent severe and/or uncontrolled medical disease Impairment of gastrointestinal (GI) function/disease Requirement for therapy with coumadin (warfarin sodium) Patient is less than 5 years free of another primary malignancy Patients unwilling to or unable to comply with the protocol Grade 2 or greater peripheral sensory neuropathy
Sites / Locations
- The Brain Tumor Center, Duke University Medical Center