Safety and Efficacy Study of Panzem NCD to Treat Glioblastoma

• Status: Completed
• Trial end date: 2008-12-01
• Target enrollment: 0
• Participant gender: All

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)

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: CASI Pharmaceuticals, Inc.
• Treatments: 2-Methoxyestradiol

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