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
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.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
determine the maximum tolerated dose
in the first 28 days following REOLYSIN® administration
James M Markert, MD
University of Alabama at Birmingham
United States: Food and Drug Administration
|Cedars-Sinai Medical Center||Los Angeles, California 90048|
|University of Alabama at Birmingham||Birmingham, Alabama 35294-3300|
|The Ohio State University Medical Center and Arthur G. James Cancer Hospital and Richard J. Solove Research Center||Columbus, Ohio 43210|