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Sponsored by: |
EntreMed |
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Information provided by: | EntreMed |
ClinicalTrials.gov Identifier: | NCT00481455 |
The purpose of this study is to evaluate the anti-tumor activity and safety of Panzem NCD given in combination with daily oral fixed-dose temozolomide in patients with recurrent glioblastoma multiforme.
Condition | Intervention | Phase |
---|---|---|
Recurrent Glioblastoma Multiforme |
Drug: Panzem NCD Drug: Temozolomide |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment |
Official Title: | A Single-Center, Open-Label, Phase II, Safety and Efficacy Study of Panzem Nanocrystal Colloidal Dispersion Administered Orally in Combination With Protracted Oral Fixed-Dose Temozolomide to Patients With Recurrent Glioblastoma Multiforme |
Enrollment: | 15 |
Study Start Date: | April 2007 |
Study Completion Date: | October 2008 |
Primary Completion Date: | September 2007 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental |
Drug: Panzem NCD
2000 mg q8h, continuous dosing in 28 day cycles
Drug: Temozolomide
Fixed dose
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, North Carolina | |
The Brain Tumor Center, Duke University Medical Center | |
Durham, North Carolina, United States, 27710 |
Principal Investigator: | Annick Desjardins, MD | Duke University |
Responsible Party: | EntreMed, Inc ( Chief Medical Officer ) |
Study ID Numbers: | ME-CLN-007 |
Study First Received: | May 30, 2007 |
Last Updated: | November 24, 2008 |
ClinicalTrials.gov Identifier: | NCT00481455 |
Health Authority: | United States: Food and Drug Administration |
Glioblastoma Multiforme temozolomide |
Neuroectodermal Tumors Glioblastoma Glioblastoma multiforme Astrocytoma 2-methoxyestradiol Neoplasms, Germ Cell and Embryonal |
Neuroepithelioma Glioma Temozolomide Recurrence Neoplasms, Glandular and Epithelial |
Disease Attributes Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Neoplasms, Nerve Tissue Mitosis Modulators Antimitotic Agents Pharmacologic Actions |
Neoplasms Pathologic Processes Therapeutic Uses Tubulin Modulators Antineoplastic Agents, Alkylating Neoplasms, Neuroepithelial Alkylating Agents |