Safety and Efficacy Study of Panzem NCD to Treat Glioblastoma

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-01-31

Study Completion Date

2008-12-31

Brief Summary

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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)

Detailed Description

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Conditions

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Recurrent Glioblastoma Multiforme

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Panzem Nanocrystal Colloidal Dispersion

Panzem NCD suspension, 100 mg/mL, four times daily continuous dosing

Intervention Type DRUG

Other Intervention Names

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2-methoxyestradiol 2ME2

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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EntreMed, Inc.

Principal Investigators

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David A. Reardon, M.D.

Role: PRINCIPAL_INVESTIGATOR

The Brain Center at Duke, Duke University Medical Center

Locations

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The Brain Tumor Center, Duke University Medical Center

Durham, North Carolina, United States

Site Status

Countries

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United States

Other Identifiers

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ME-CLN-005

Identifier Type: -

Identifier Source: org_study_id