Safety and Efficacy Study of Panzem NCD to Treat Glioblastoma

This study has been completed.
Sponsor:
Information provided by:
CASI Pharmaceuticals, Inc.
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 CASI Pharmaceuticals, Inc.:

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
CASI Pharmaceuticals, Inc.
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 September 18, 2014