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Safety and Efficacy Study of Panzem NCD to Treat Glioblastoma

Primary Purpose

Recurrent Glioblastoma Multiforme

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Panzem Nanocrystal Colloidal Dispersion
Sponsored by
CASI Pharmaceuticals, Inc.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Recurrent Glioblastoma Multiforme

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The Brain Tumor Center, Duke University Medical Center

Outcomes

Primary Outcome Measures

6 month progression free survival and median overall survival

Secondary Outcome Measures

Full Information

First Posted
March 22, 2006
Last Updated
December 9, 2008
Sponsor
CASI Pharmaceuticals, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00306618
Brief Title
Safety and Efficacy Study of Panzem NCD to Treat Glioblastoma
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2008
Overall Recruitment Status
Completed
Study Start Date
January 2006 (undefined)
Primary Completion Date
November 2007 (Actual)
Study Completion Date
December 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
CASI Pharmaceuticals, Inc.

4. Oversight

5. Study Description

Brief Summary
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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Recurrent Glioblastoma Multiforme

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
27 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Panzem Nanocrystal Colloidal Dispersion
Other Intervention Name(s)
2-methoxyestradiol, 2ME2
Intervention Description
Panzem NCD suspension, 100 mg/mL, four times daily continuous dosing
Primary Outcome Measure Information:
Title
6 month progression free survival and median overall survival
Time Frame
time of progression; survival

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David A. Reardon, M.D.
Organizational Affiliation
The Brain Center at Duke, Duke University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Brain Tumor Center, Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Safety and Efficacy Study of Panzem NCD to Treat Glioblastoma

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