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Safety and Efficacy Study of Panzem NCD to Treat Glioblastoma

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00306618
First Posted: March 24, 2006
Last Update Posted: December 10, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
CASI Pharmaceuticals, Inc.
  Purpose
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)

Condition Intervention Phase
Recurrent Glioblastoma Multiforme Drug: Panzem Nanocrystal Colloidal Dispersion Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by CASI Pharmaceuticals, Inc.:

Primary Outcome Measures:
  • 6 month progression free survival and median overall survival [ Time Frame: time of progression; survival ]

Enrollment: 27
Study Start Date: January 2006
Study Completion Date: December 2008
Primary Completion Date: November 2007 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Panzem Nanocrystal Colloidal Dispersion
    Panzem NCD suspension, 100 mg/mL, four times daily continuous dosing
    Other Names:
    • 2-methoxyestradiol
    • 2ME2
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00306618


Locations
United States, North Carolina
The Brain Tumor Center, Duke University Medical Center
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
CASI Pharmaceuticals, Inc.
Investigators
Principal Investigator: David A. Reardon, M.D. The Brain Center at Duke, Duke University Medical Center
  More Information

Responsible Party: Chief Medical Officer, EntreMed, Inc.
ClinicalTrials.gov Identifier: NCT00306618     History of Changes
Other Study ID Numbers: ME-CLN-005
First Submitted: March 22, 2006
First Posted: March 24, 2006
Last Update Posted: December 10, 2008
Last Verified: December 2008

Additional relevant MeSH terms:
Glioblastoma
Astrocytoma
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
2-methoxyestradiol
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents