Safety and Efficacy Study of Panzem NCD to Treat Glioblastoma

December 9, 2008 updated by: CASI Pharmaceuticals, Inc.

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

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)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

27

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • The Brain Tumor Center, Duke University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
6 month progression free survival and median overall survival
Time Frame: time of progression; survival
time of progression; survival

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CASI Pharmaceuticals, Inc.

Investigators

  • Principal Investigator: David A. Reardon, M.D., The Brain Center at Duke, Duke University Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2006

Primary Completion (Actual)

November 1, 2007

Study Completion (Actual)

December 1, 2008

Study Registration Dates

First Submitted

March 22, 2006

First Submitted That Met QC Criteria

March 22, 2006

First Posted (Estimate)

March 24, 2006

Study Record Updates

Last Update Posted (Estimate)

December 10, 2008

Last Update Submitted That Met QC Criteria

December 9, 2008

Last Verified

December 1, 2008

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ME-CLN-005

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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