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Sponsored by: |
IVAX Research LLC |
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Information provided by: | IVAX Research LLC |
ClinicalTrials.gov Identifier: | NCT00104091 |
Immunotoxin therapy may be effective in treating malignant glioma. Immunotoxins can locate tumor cells and kill them without harming normal cells.
Condition | Intervention | Phase |
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Glioblastoma Multiforme |
Drug: TP-38 |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Multicenter Phase II Study of TP-38 in Those Patients With Glioblastoma Multiforme Who Have Recurred or Progressed After Previous Resection and Radiation Therapy and Are Scheduled for Gross Total Resection |
Estimated Enrollment: | 56 |
Study Start Date: | December 2004 |
Study Completion Date: | June 2007 |
Primary Completion Date: | April 2007 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
40 mL of TP-38 at a 100 nanograms/mL concentration
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Drug: TP-38
TP-38 is a recombinant chimeric protein composed of the epidermal growth factor (EGFR) binding ligand (TGF-α)and a genetically engineered form of the Pseudomonas exotoxin, PE-38.
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
The patients must fulfill all the following criteria:
Exclusion Criteria:
Patients fulfilling any of the following criteria should not be enrolled in the study:
Responsible Party: | Teva Neuroscience ( Rivka Kreitman, Ph.D., Vice President, Innovative Research and Development ) |
Study ID Numbers: | IXR-202-22-188 |
Study First Received: | February 22, 2005 |
Last Updated: | March 31, 2008 |
ClinicalTrials.gov Identifier: | NCT00104091 |
Health Authority: | United States: Food and Drug Administration |
Gross Total Resection Convection Enhanced Delivery Recurrent Glioblastoma Multiforme |
Neuroectodermal Tumors Brain Neoplasms Glioblastoma Glioblastoma multiforme Astrocytoma |
Neoplasms, Germ Cell and Embryonal Neuroepithelioma Glioma Recurrence Neoplasms, Glandular and Epithelial |
Neoplasms Neoplasms by Histologic Type Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial |