Safety and Efficacy Study of REOLYSIN® in the Treatment of Recurrent Malignant Gliomas
|ClinicalTrials.gov Identifier: NCT00528684|
Recruitment Status : Completed
First Posted : September 12, 2007
Last Update Posted : October 2, 2014
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 or disease||Intervention/treatment||Phase|
|Malignant Glioma||Biological: REOLYSIN®||Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||18 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||July 2006|
|Actual Primary Completion Date :||April 2010|
|Actual Study Completion Date :||June 2010|
- Biological: REOLYSIN®
REOLYSIN® is administered as a single intratumoral infusion over 72 hours. Dose levels in Phase 1 will be 1x10E8, 3x10E8, 1x10E9, 3x10E9, 1x10E10 TCID50. The dose level for Phase 2 will be the top dose reached in Phase 1.
- determine the maximum tolerated dose [ Time Frame: in the first 28 days following REOLYSIN® administration ]
- and response rate of treated tumors [ Time Frame: evaluated monthly for 6 months following REOLYSIN® administration ]
- determine the dose limiting toxicity [ Time Frame: in the first 28 days following REOLYSIN® administration ]
- Determine the patient survival [ Time Frame: patients are in follow up for up to six months ]
- functional status using the Karnofsky Performance Status scale and Clinical Neurological Assessment [ Time Frame: evaluated monthly for up to 6 months ]
- time to progression for the treated tumor [ Time Frame: evaluated monthly for up to 6 months ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00528684
|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|