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CompletedNCT00306618Updated Dec 10, 2008

Safety and Efficacy Study of Panzem NCD to Treat Glioblastoma

A Phase 2 interventional study of Panzem Nanocrystal Colloidal Dispersion in Recurrent Glioblastoma Multiforme, sponsored by CASI Pharmaceuticals, Inc.. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2008-12-10.

Sponsored by CASI Pharmaceuticals, Inc. · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
27
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
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Study 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)

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Conditions studied

  • Recurrent Glioblastoma Multiforme

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03

In context

Glioblastoma

1,920 studies on the registry are indexed under Glioblastoma; 450 are open to participants now.

This study's enrollment of 27 is below the median of 36 across 1,618 interventional studies indexed under Glioblastoma.

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Lead sponsor

CASI Pharmaceuticals, Inc. is the lead sponsor of 22 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
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Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
27 participants (actual)

Interventions

  • DrugPanzem Nanocrystal Colloidal Dispersion

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

    Also known as: 2-methoxyestradiol, 2ME2

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What researchers measure

Primary outcomes

  1. 6 month progression free survival and median overall survival

    Time frame: time of progression; survival

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Study locations

1 site
  • The Brain Tumor Center, Duke University Medical Center
    Durham, North Carolina 27710, United States
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 10, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00306618
Lead sponsor
CASI Pharmaceuticals, Inc.
First posted
Mar 24, 2006
Start date
Jan 2006
Primary completion
Nov 2007
Completion
Dec 2008
Last update
Dec 10, 2008

Study contacts

David A. Reardon, M.D.
principal investigator · The Brain Center at Duke, Duke University Medical Center
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2008. You cannot join it, but the record below documents what was studied.

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