Viral Therapy in Treating Young Patients With Relapsed or Refractory Solid Tumors
|Unspecified Childhood Solid Tumor, Protocol Specific||Biological: wild-type reovirus Drug: cyclophosphamide Other: laboratory biomarker analysis Other: pharmacological study||Phase 1|
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||A Phase 1 Dose Escalation Study of Reolysin, a Replication Competent Reovirus, in Pediatric Patients With Relapsed or Refractory Solid Tumors|
- Maximum-tolerated dose (MTD), defined as the maximum dose at which fewer than one-third of patients experience dose-limiting toxicity (DLT), graded using the NCI CTCAE v. 4.0 [ Time Frame: Up to 28 days ]
- Time course of viral clearance of wild-type reovirus [ Time Frame: Up to 3 months ]Summarized with simple summary statistics, including means, medians, ranges, and standard deviations (if numbers and distribution permit).
- Development of neutralizing antibodies to wild-type reovirus [ Time Frame: Up to 3 months ]Summarized with simple summary statistics, including means, medians, ranges, and standard deviations (if numbers and distribution permit).
- Disease response, assessed according to Response Evaluation Criteria in Solid Tumors (RECIST) [ Time Frame: Up to 1 year ]Will be reported descriptively.
|Study Start Date:||December 2010|
|Primary Completion Date:||April 2014 (Final data collection date for primary outcome measure)|
Experimental: Treatment (virus and chemotherapy)
Patients receive wild-type reovirus IV over 60 minutes QD on days 1-5. Some patients also receive cyclophosphamide PO on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
Biological: wild-type reovirus
Other Name: REOLYSINDrug: cyclophosphamide
Other Names:Other: laboratory biomarker analysis
Correlative studiesOther: pharmacological study
Other Name: pharmacological studies
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01240538
Hide Study Locations
|United States, Alabama|
|Children's Hospital of Alabama|
|Birmingham, Alabama, United States, 35233|
|United States, Arizona|
|Phoenix Childrens Hospital|
|Phoenix, Arizona, United States, 85016|
|United States, California|
|Children's Hospital Los Angeles|
|Los Angeles, California, United States, 90027|
|Childrens Hospital of Orange County|
|Orange, California, United States, 92868-3874|
|University of California San Francisco Medical Center-Parnassus|
|San Francisco, California, United States, 94143|
|United States, Delaware|
|Alfred I duPont Hospital for Children|
|Wilmington, Delaware, United States, 19803|
|United States, District of Columbia|
|Children's National Medical Center|
|Washington, District of Columbia, United States, 20010|
|United States, Florida|
|Nemours Children's Clinic - Jacksonville|
|Jacksonville, Florida, United States, 32207-8426|
|United States, Illinois|
|Lurie Children's Hospital-Chicago|
|Chicago, Illinois, United States, 60614|
|United States, Indiana|
|Indiana University Medical Center|
|Indianapolis, Indiana, United States, 46202|
|Riley Hospital for Children|
|Indianapolis, Indiana, United States, 46202|
|United States, Michigan|
|C S Mott Children's Hospital|
|Ann Arbor, Michigan, United States, 48109|
|United States, Minnesota|
|University of Minnesota Medical Center-Fairview|
|Minneapolis, Minnesota, United States, 55455|
|United States, New York|
|Montefiore Medical Center|
|Bronx, New York, United States, 10467-2490|
|Columbia University Medical Center|
|New York, New York, United States, 10032|
|United States, Ohio|
|Cincinnati Children's Hospital Medical Center|
|Cincinnati, Ohio, United States, 45229|
|United States, Oklahoma|
|University of Oklahoma Health Sciences Center|
|Oklahoma City, Oklahoma, United States, 73104|
|United States, Oregon|
|Oregon Health and Science University|
|Portland, Oregon, United States, 97239|
|United States, Pennsylvania|
|Children's Hospital of Pittsburgh of UPMC|
|Pittsburgh, Pennsylvania, United States, 15224|
|United States, Tennessee|
|St. Jude Children's Research Hospital|
|Memphis, Tennessee, United States, 38105|
|United States, Texas|
|University of Texas Southwestern Medical Center|
|Dallas, Texas, United States, 75390|
|Cook Children's Medical Center|
|Fort Worth, Texas, United States, 76104|
|Baylor College of Medicine|
|Houston, Texas, United States, 77030|
|United States, Washington|
|Seattle Children's Hospital|
|Seattle, Washington, United States, 98105|
|United States, Wisconsin|
|Midwest Children's Cancer Center|
|Milwaukee, Wisconsin, United States, 53226|
|Hospital for Sick Children|
|Toronto, Ontario, Canada, M5G 1X8|
|Centre Hospitalier Universitaire Sainte-Justine|
|Montreal, Quebec, Canada, H3T 1C5|
|Principal Investigator:||E. Anders Kolb||COG Phase I Consortium|