Safety and Efficacy Study of Panzem NCD to Treat Glioblastoma

NCT00306618 | Completed Phase 2

• 1 other identifier: ME-CLN-005
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

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)

Conditions

Recurrent Glioblastoma Multiforme

Outcome Measures

Primary Outcomes (1)

• 6 month progression free survival and median overall survival

  time of progression; survival

Interventions

Panzem Nanocrystal Colloidal Dispersion DRUG

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

Also known as: 2-methoxyestradiol, 2ME2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically confirmed diagnosis of a 1st or 2nd recurrent/progressive primary WHO grade IV malignant glioma (glioblastoma multiforme or gliosarcoma).
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• CASI Pharmaceuticals, Inc.: lead

Study Sites (1)

The Brain Tumor Center, Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Glioblastoma

Interventions

2-Methoxyestradiol

Condition Hierarchy (Ancestors)

Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Estradiol; Estrenes; Estranes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• David A. Reardon, M.D.

  The Brain Center at Duke, Duke University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: March 22, 2006
• First Posted: March 24, 2006
• Study Start: January 1, 2006
• Primary Completion: November 1, 2007
• Study Completion: December 1, 2008
• Last Updated: December 10, 2008

Record last verified: 2008-12

Locations

US (1)