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Safety and Efficacy Study of Panzem NCD to Treat Glioblastoma
This study has been completed.
Sponsored by: EntreMed
Information provided by: EntreMed
ClinicalTrials.gov Identifier: NCT00306618
  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 II

MedlinePlus related topics: Cancer
Drug Information available for: 2-Methoxyestradiol
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
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

Further study details as provided by EntreMed:

Primary Outcome Measures:
  • 6 month progression free survival and median overall survival [ Time Frame: time of progression; survival ] [ Designated as safety issue: No ]

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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00306618

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

Responsible Party: EntreMed, Inc. ( Chief Medical Officer )
Study ID Numbers: ME-CLN-005
Study First Received: March 22, 2006
Last Updated: December 9, 2008
ClinicalTrials.gov Identifier: NCT00306618  
Health Authority: United States: Food and Drug Administration

Study placed in the following topic categories:
Neuroectodermal Tumors
Glioblastoma
Glioblastoma multiforme
Astrocytoma
2-methoxyestradiol
Neoplasms, Germ Cell and Embryonal
Neuroepithelioma
Glioma
Recurrence
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:
Disease Attributes
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Neoplasms, Nerve Tissue
Mitosis Modulators
Antimitotic Agents
Pharmacologic Actions
Neoplasms
Pathologic Processes
Therapeutic Uses
Tubulin Modulators
Neoplasms, Neuroepithelial

ClinicalTrials.gov processed this record on January 14, 2009