Safety and Efficacy Study of Panzem NCD to Treat Glioblastoma
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
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This single-center, open-label, phase 2 study will evaluate the anti-tumor activity, as well as the safety and pharmacokinetics, of Panzem (2-methoxyestradiol, 2ME2) Nanocrystal Colloidal Dispersion (NCD) administered in patients with recurrent glioblastoma multiforme (GBM)
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Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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
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