Safety and Efficacy Study of Panzem NCD to Treat Glioblastoma

CASI Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Recurrent Glioblastoma Multiforme

Treatments: Drug: Panzem Nanocrystal Colloidal Dispersion

Study type: Interventional

Funder types: Industry

Identifiers

NCT00306618

ME-CLN-005

Details and patient eligibility

About

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)

Enrollment: 27 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)