Safety and Efficacy Study of Panzem NCD to Treat Glioblastoma

Recurrent Glioblastoma Multiforme Clinical Trial

Official title:

A Single-Center, Open-Label, Phase II, Safety, Pharmacokinetic and Efficacy of Panzem Nanocrystal Colloidal Dispersion Administered Orally to Patients With Recurrent Glioblastoma Multiforme

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00306618
• Other study ID #: ME-CLN-005
• Status: Completed
• Phase: Phase 2
• First received: March 22, 2006
• Last updated: December 9, 2008
• Start date: January 2006
• Est. completion date: December 2008

Study information

• Verified date: December 2008
• Source: CASI Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: December 2008
• Est. primary completion date: November 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Glioblastoma
• Recurrent Glioblastoma Multiforme

Intervention

Drug:
• Panzem Nanocrystal Colloidal Dispersion
Panzem NCD suspension, 100 mg/mL, four times daily continuous dosing

Locations

Country	Name	City	State
United States	The Brain Tumor Center, Duke University Medical Center	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
CASI Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	6 month progression free survival and median overall survival		time of progression; survival	No