Spots Global Cancer Trial Database for Viral Therapy in Treating Young Patients With Relapsed or Refractory Solid Tumors
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Trial Identification
Brief Title: Viral Therapy in Treating Young Patients With Relapsed or Refractory Solid Tumors
Official Title: A Phase 1 Dose Escalation Study of Reolysin, a Replication Competent Reovirus, in Pediatric Patients With Relapsed or Refractory Solid Tumors
Study ID: NCT01240538
Study Description
Brief Summary: This phase I trial studies the side effects and the best dose of viral therapy in treating young patients with solid tumors that have come back or that have not responded to standard therapy. Some tumors have cells with a genetic weakness that makes them unable to fight off a virus called wild-type reovirus. The virus causes cells with this weakness to die, and may therefore be able to kill tumor cells without damaging normal cells. Cyclophosphamide is a drug used in chemotherapy that stops tumor cells from dividing and causes them to die. Giving wild-type reovirus together with cyclophosphamide may kill more tumor cells.
Detailed Description: PRIMARY OBJECTIVES: I. To estimate the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of REOLYSIN (wild-type reovirus) administered as an intravenous infusion daily for 5 days, every 28 days to 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 patients. IV. To characterize the pharmacokinetics (time course of viral clearance) of Reolysin in children with refractory cancer. SECONDARY OBJECTIVES: 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. Patients receive wild-type reovirus intravenously (IV) over 60 minutes once daily (QD) on days 1-5. Some patients also receive cyclophosphamide orally (PO) 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.
Keywords
Eligibility
Minimum Age: 3 Years
Eligible Ages: CHILD, ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Children's Hospital of Alabama, Birmingham, Alabama, United States
Phoenix Childrens Hospital, Phoenix, Arizona, United States
Children's Hospital Los Angeles, Los Angeles, California, United States
Childrens Hospital of Orange County, Orange, California, United States
University of California San Francisco Medical Center-Parnassus, San Francisco, California, United States
Alfred I duPont Hospital for Children, Wilmington, Delaware, United States
Children's National Medical Center, Washington, District of Columbia, United States
Nemours Children's Clinic - Jacksonville, Jacksonville, Florida, United States
Lurie Children's Hospital-Chicago, Chicago, Illinois, United States
Indiana University Medical Center, Indianapolis, Indiana, United States
Riley Hospital for Children, Indianapolis, Indiana, United States
C S Mott Children's Hospital, Ann Arbor, Michigan, United States
University of Minnesota Medical Center-Fairview, Minneapolis, Minnesota, United States
Montefiore Medical Center, Bronx, New York, United States
Columbia University Medical Center, New York, New York, United States
Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, United States
University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma, United States
Oregon Health and Science University, Portland, Oregon, United States
Children's Hospital of Pittsburgh of UPMC, Pittsburgh, Pennsylvania, United States
St. Jude Children's Research Hospital, Memphis, Tennessee, United States
University of Texas Southwestern Medical Center, Dallas, Texas, United States
Cook Children's Medical Center, Fort Worth, Texas, United States
Baylor College of Medicine, Houston, Texas, United States
Seattle Children's Hospital, Seattle, Washington, United States
Midwest Children's Cancer Center, Milwaukee, Wisconsin, United States
Hospital for Sick Children, Toronto, Ontario, Canada
Centre Hospitalier Universitaire Sainte-Justine, Montreal, Quebec, Canada
Contact Details
Name: E. Anders Kolb
Affiliation: COG Phase I Consortium
Role: PRINCIPAL_INVESTIGATOR
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