NCT00306618
Completed
Phase 2
A Single-Center, Open-Label, Phase II, Safety, Pharmacokinetic and Efficacy of Panzem Nanocrystal Colloidal Dispersion Administered Orally to Patients With Recurrent Glioblastoma Multiforme
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Recurrent Glioblastoma Multiforme
- Sponsor
- CASI Pharmaceuticals, Inc.
- Enrollment
- 27
- Locations
- 1
- Primary Endpoint
- 6 month progression free survival and median overall survival
- Status
- Completed
- Last Updated
- 17 years ago
Overview
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)
Investigators
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
Outcomes
Primary Outcomes
6 month progression free survival and median overall survival
Time Frame: time of progression; survival
Study Sites (1)
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