Safety and Efficacy Study of Panzem NCD to Treat Glioblastoma

This study has been completed.
Sponsor:
Information provided by:
EntreMed
ClinicalTrials.gov Identifier:
NCT00306618
First received: March 22, 2006
Last updated: December 9, 2008
Last verified: December 2008
  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
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 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
    Other Names:
    • 2-methoxyestradiol
    • 2ME2
  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

No publications provided

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

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
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 16, 2014