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| Sponsor: | Oncolytics Biotech |
|---|---|
| Information provided by (Responsible Party): | Oncolytics Biotech |
| ClinicalTrials.gov Identifier: | NCT00528684 |
Purpose
RATIONALE: Oncolytic viruses such as reovirus (REOLYSIN®) can specifically kill tumor cells while leaving healthy cells unharmed.
PURPOSE: This phase I/II study investigates the maximum tolerated dose (MTD), dose limiting toxicity (DLT) and anti-tumor effect of intralesional administration of REOLYSIN® therapeutic reovirus in patients with malignant glioma with evaluable disease which is progressive/recurrent despite surgery and/or radiotherapy with or without chemotherapy. (The phase I portion of the study is currently enrolling patients.)
| Condition | Intervention | Phase |
|---|---|---|
|
Malignant Glioma |
Biological: REOLYSIN® |
Phase I |
| 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 I/II Clinical Trial to Evaluate Dose Limiting Toxicity and Efficacy of Intralesional Administration of REOLYSIN® for the Treatment of Patients With Histologically Confirmed Recurrent Malignant Gliomas |
| Enrollment: | 18 |
| Study Start Date: | July 2006 |
| Study Completion Date: | June 2010 |
| Primary Completion Date: | April 2010 (Final data collection date for primary outcome measure) |
Oncolytic viruses, such as reovirus, are those viruses which specifically destroy cancer cells. Reovirus is a common virus that does not cause disease, and has been shown to be associated with only minor flu-like symptoms. REOLYSIN® is a formulation of the live, replication-competent wild-type reovirus that selectively replicates in tumor cells, while leaving healthy cells unharmed.
This phase I/II multi-center study follows a standard design utilizing therapeutic viral dosage escalation. The phase I portion of the trial will evaluate the doses of intralesional REOLYSIN titrated to a maximum tolerated dose (MTD). The objective of the phase II portion of the study is to assess tumor response. The proportion of patients surviving to six months and the safety of REOLYSIN® are secondary objectives.
Each patient enrolled in the study will receive a single infusion of REOLYSIN® over 72 hours. Patients will remain in hospital for at least 90 hours after initiation of infusion. Following REOLYSIN® administration, each patient will be followed for at least 12 weeks (Phase I) and at least 6 months (Phase II) with regular evaluation visits (weekly and then monthly). Evaluations will include tumor measurements, serial neurologic exams and functional performance status assessments at baseline, prior to hospital discharge, and at weeks 4, 8, 12, 16 and 24 after REOLYSIN® therapy. Changes in performance will be assessed using the Karnofsky Performance Status scale. Subjects will also undergo serial blood sampling for evaluation of viral RNA, hematology and biochemistry.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Abbreviated Inclusion Criteria:
Abbreviated Exclusion Criteria:
Contacts and Locations| United States, Alabama | |
| University of Alabama at Birmingham | |
| Birmingham, Alabama, United States, 35294 | |
| United States, California | |
| Cedars-Sinai Medical Center | |
| Los Angeles, California, United States, 90048 | |
| United States, Ohio | |
| The Ohio State University Medical Center and Arthur G. James Cancer Hospital and Richard J. Solove Research Center | |
| Columbus, Ohio, United States, 43210 | |
| Principal Investigator: | James M Markert, MD | University of Alabama at Birmingham |
More Information
| Responsible Party: | Oncolytics Biotech |
| ClinicalTrials.gov Identifier: | NCT00528684 History of Changes |
| Other Study ID Numbers: | REO 007 |
| Study First Received: | September 10, 2007 |
| Last Updated: | September 2, 2011 |
| Health Authority: | United States: Food and Drug Administration |
|
Oncolytics Biotech cancer alternative therapies malignant glioma glioblastoma multiforme |
oncolytic virus reovirus REOLYSIN |
|
Glioma Neoplasms, Neuroepithelial Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal |
Neoplasms by Histologic Type Neoplasms Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue |