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Sponsored by: |
Protherics |
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Information provided by: | Protherics |
ClinicalTrials.gov Identifier: | NCT00479765 |
OncoGel™ is a new, experimental drug delivery system that allows the slow continuous release of paclitaxel (an approved intravenous anticancer drug), from a gel (ReGel™) over a long period of time. The gel will disappear in 4 to 6 weeks as it releases the paclitaxel.
The purpose of this study is to evaluate the safety and tolerability of OncoGel when placed into the tumor resection cavity in the brain following surgical removal of the tumor. Dose escalation is conducted by gradually increasing the amount of OncoGel placed in the resection cavity in small groups of patients, and watching the patients closely for side effects before moving to the next dose level. The study will also test whether OncoGel helps to prevent or delay the tumor from regrowing.
Condition | Intervention | Phase |
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Glioblastoma Multiforme Brain Neoplasms |
Drug: OncoGel (ReGel/Paclitaxel) |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Phase 1 / 2 Dose Escalation Study of Locally-Administered OncoGel™ in Subjects With Recurrent Glioma |
Enrollment: | 4 |
Study Start Date: | March 2007 |
Estimated Study Completion Date: | November 2010 |
Estimated Primary Completion Date: | November 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
OncoGel administered into remaining cavity after surgical resection. Each dose cohort will receive a different volume of OncoGel
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Drug: OncoGel (ReGel/Paclitaxel)
OncoGel administered into cavity after surgical resection of recurrent glioma. Each subject will receive one dose of OncoGel on the day of surgical resection.
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This study is for patients with recurrent glioblastoma multiforme. Because most recurrences are in the area of the original resection, local delivery of a chemotherapeutic agent may prevent or delay additional recurrences. Paclitaxel has demonstrated activity against 9L glioma tumor lines, but has poor central nervous system penetration after intravenous administration. OncoGel is a new formulation of paclitaxel in a bioerodible gel that can be administered directly to the brain, thereby bypassing the blood-brain barrier.
Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Bilirubin >2.0 mg/dL; Aspartate transaminase (AST) >2.5 times the normal limit; Alanine aminotransferase (ALT) >2.5 times the normal limit.
Hematopoietic Status: Absolute neutrophil count (ANC) <1500mm3; Platelet count <100,000/mm3; Hemoglobin < 10 g/dL. Hemostatic: Prothrombin Time (PT) or INR above normal range; Partial Thromboplastin Time (PTT) above normal range; Bleeding Time outside normal range (if performed by hospital). Renal Status: Serum creatinine >2 mg/dL.
United States, Illinois | |
The University of Chicago Brain Tumor Center | |
Chicago, Illinois, United States, 60637 | |
United States, Maryland | |
The Johns Hopkins University | |
Baltimore, Maryland, United States, 21231 | |
United States, New York | |
University of Rochester Medical Center | |
Rochester, New York, United States, 14642 | |
United States, North Carolina | |
University of North Carolina at Chapel Hill | |
Chapel Hill, North Carolina, United States, 27599 | |
United States, Tennessee | |
Vanderbilt University Medical Center | |
Nashville, Tennessee, United States, 37212 |
Principal Investigator: | Maciej S Lesniak, MD | University of Chicago |
Responsible Party: | Protherics ( Claire Daugherty, Clinical Project Manager ) |
Study ID Numbers: | PR016-CLN-pro002, OGL-109 |
Study First Received: | May 24, 2007 |
Last Updated: | April 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00479765 History of Changes |
Health Authority: | United States: Food and Drug Administration |
glioblastoma multiforme recurrent Phase 1 Phase 2 Phase I Phase II brain cancer paclitaxel |
intracranial tumor local chemotherapy brain tumor brain cancer glioma OncoGel |
Glioblastoma Astrocytoma Central Nervous System Diseases Antimitotic Agents Central Nervous System Neoplasms Brain Diseases Recurrence Brain Neoplasms Neuroectodermal Tumors |
Paclitaxel Neoplasms, Germ Cell and Embryonal Tubulin Modulators Neuroepithelioma Glioma Glioblastoma Multiforme Antineoplastic Agents, Phytogenic Nervous System Neoplasms Neoplasms, Glandular and Epithelial |
Glioblastoma Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Neoplasms, Nerve Tissue Central Nervous System Neoplasms Brain Diseases Neoplasms by Site Therapeutic Uses Neoplasms, Germ Cell and Embryonal Glioma Nervous System Neoplasms Neoplasms by Histologic Type Astrocytoma |
Nervous System Diseases Mitosis Modulators Central Nervous System Diseases Antimitotic Agents Pharmacologic Actions Neuroectodermal Tumors Brain Neoplasms Neoplasms Paclitaxel Tubulin Modulators Neoplasms, Neuroepithelial Antineoplastic Agents, Phytogenic Neoplasms, Glandular and Epithelial |