Recurrent Glioblastoma Multiforme
Conditions
Brief summary
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)
Interventions
DRUGPanzem Nanocrystal Colloidal Dispersion
Panzem NCD suspension, 100 mg/mL, four times daily continuous dosing
Sponsors
CASI Pharmaceuticals, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 6 month progression free survival and median overall survival | time of progression; survival |
Countries
United States
Outcome results
None listed