A Phase 1 Dose Escalation Study of Reolysin, a Replication Competent Reovirus, in Pediatric Patients With Relapsed or Refractory Solid Tumors
I. To estimate the maximum-tolerated dose (MTD) and/or recommended phase II dose of
wild-type reovirus (Reolysin) in children with relapsed or refractory solid tumors.
II. To define and describe the toxicities of Reolysin in these patients. III. To define the
toxicity and tolerability of combining Reolysin with oral cyclophosphamide in these
IV. To characterize the pharmacokinetics (time course of viral clearance) of Reolysin in
children with refractory cancer.
I. To define the antitumor activity of Reolysin within the confines of a phase I study.
II. To evaluate the development of neutralizing antibodies to Reolysin following intravenous
administration of Reolysin alone and in combination with cyclophosphamide.
III. To assess the biologic activity of Reolysin.
OUTLINE: This is a dose-escalation study of wild-type reovirus (Reolysin).
Patients receive Reolysin IV over 60 minutes once daily on days 1-5. Some patients also
receive oral cyclophosphamide on days 1-21. Treatment repeats every 28 days for up to 12
courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up periodically for up to 1 year.
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Maximum-tolerated dose (MTD), defined as the maximum dose at which fewer than one-third of patients experience DLT, graded using the NCI CTCAE version 4.0
Up to 28 days
E. Anders Kolb
Children's Oncology Group
United States: Food and Drug Administration
|Baylor College of Medicine||Houston, Texas 77030|
|Washington University School of Medicine||Saint Louis, Missouri 63110|
|Midwest Children's Cancer Center||Milwaukee, Wisconsin 53226|
|Children's Hospital Los Angeles||Los Angeles, California 90027-0700|
|Children's National Medical Center||Washington, District of Columbia 20010-2970|
|University of Oklahoma Health Sciences Center||Oklahoma City, Oklahoma 73104|
|St. Jude Children's Research Hospital||Memphis, Tennessee 38105-2794|
|Cincinnati Children's Hospital Medical Center||Cincinnati, Ohio 45229-3039|
|Montefiore Medical Center||Bronx, New York 10467-2490|
|Children's Hospital of Pittsburgh of UPMC||Pittsburgh, Pennsylvania 15213|
|University of Alabama at Birmingham||Birmingham, Alabama 35294-3300|
|Children's Hospital of Alabama||Birmingham, Alabama 35233|
|University of Texas Southwestern Medical Center||Dallas, Texas|
|Oregon Health and Science University||Portland, Oregon 97201|
|Seattle Children's Hospital||Seattle, Washington 98105|
|Childrens Memorial Hospital||Chicago, Illinois 60614|
|Columbia University Medical Center||New York, New York 10032|
|Cook Children's Medical Center||Fort Worth, Texas 76104|
|University of Minnesota Medical Center-Fairview||Minneapolis, Minnesota 55455|
|Children's Oncology Group||Arcadia, California 91006-3776|
|C S Mott Children's Hospital||Ann Arbor, Michigan 48109|
|Riley Hospital for Children||Indianapolis, Indiana 46202|
|Phoenix Childrens Hospital||Phoenix, Arizona 85016|
|Childrens Hospital of Orange County||Orange, California 92868-3874|
|Alfred I duPont Hospital for Children||Wilmington, Delaware 19803|
|Nemours Children's Clinic - Jacksonville||Jacksonville, Florida 32207-8426|
|University of California San Francisco Medical Center-Parnassus||San Francisco, California 94143|