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| Sponsor: | Protherics |
|---|---|
| Information provided by: | Protherics |
| ClinicalTrials.gov Identifier: | NCT00479765 |
Purpose
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 |
|---|---|---|
|
Glioblastoma Multiforme Brain Neoplasms |
Drug: OncoGel (ReGel/Paclitaxel) |
Phase I Phase II |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
|---|---|
|
Experimental: 1
OncoGel administered into remaining cavity after surgical resection. Each dose cohort will receive a different volume of OncoGel
|
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.
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| 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 |
More Information
| Responsible Party: | Claire Daugherty, Clinical Project Manager, Protherics |
| ClinicalTrials.gov Identifier: | NCT00479765 History of Changes |
| Other Study ID Numbers: | PR016-CLN-pro002, OGL-109 |
| Study First Received: | May 24, 2007 |
| Last Updated: | April 6, 2009 |
| 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 |
|
Brain Neoplasms Neoplasms Glioblastoma Glioma Central Nervous System Neoplasms Nervous System Neoplasms Neoplasms by Site Brain Diseases Central Nervous System Diseases Nervous System Diseases Astrocytoma Neoplasms, Neuroepithelial Neuroectodermal Tumors |
Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Paclitaxel Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents, Phytogenic Antineoplastic Agents Therapeutic Uses |