Safety and Efficacy Study of Panzem NCD to Treat Glioblastoma
Completed · Phase 2
Conditions studied: Recurrent Glioblastoma Multiforme
In brief
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)
Key facts
- Study ID
- NCT00306618
- Run by
- CASI pharmaceuticals, Inc.
- People needed
- 27
- Starts
- 2006-01-01
- Expected to finish
- 2008-12-01
- Last updated by the study team
- 2008-12-10
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- The Brain Tumor Center, Duke University Medical Center — Durham, North Carolina, United States
Full record on ClinicalTrials.gov
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