Status:
COMPLETED
Safety and Efficacy Study of Panzem NCD to Treat Glioblastoma
Lead Sponsor:
CASI Pharmaceuticals, Inc.
Conditions:
Recurrent Glioblastoma Multiforme
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 (...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2008
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT00306618
Start Date
January 1 2006
End Date
December 1 2008
Last Update
December 10 2008
Active Locations (1)
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1
The Brain Tumor Center, Duke University Medical Center
Durham, North Carolina, United States, 27710