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A Single-Center, Open-Label, Phase II, Safety, Pharmacokinetic and Efficacy of Panzem Nanocrystal Colloidal Dispersion Administered Orally to Patients With Recurrent Glioblastoma Multiforme


Phase 2
18 Years
N/A
Not Enrolling
Both
Recurrent Glioblastoma Multiforme

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Trial Information

A Single-Center, Open-Label, Phase II, Safety, Pharmacokinetic and Efficacy of Panzem Nanocrystal Colloidal Dispersion Administered Orally to Patients With Recurrent Glioblastoma Multiforme


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

6 month progression free survival and median overall survival

Outcome Time Frame:

time of progression; survival

Safety Issue:

No

Principal Investigator

David A. Reardon, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

The Brain Center at Duke, Duke University Medical Center

Authority:

United States: Food and Drug Administration

Study ID:

ME-CLN-005

NCT ID:

NCT00306618

Start Date:

January 2006

Completion Date:

December 2008

Related Keywords:

  • Recurrent Glioblastoma Multiforme
  • Glioblastoma

Name

Location

The Brain Tumor Center, Duke University Medical CenterDurham, North Carolina  27710