Spots Global Cancer Trial Database for Study Evaluating Biomarkers In Relapsed/Refractory Pediatric Solid Tumors
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Trial Identification
Brief Title: Study Evaluating Biomarkers In Relapsed/Refractory Pediatric Solid Tumors
Official Title: A Phase I/II Safety and Exploratory Pharmacogenomic/Pharmacodynamic Study of Intravenous Temsirolimus (CCI-779) in Pediatric Subjects With Relapsed/Refractory Solid Tumors
Study ID: NCT00106353
Interventions
Study Description
Brief Summary: This is an open label, two-part study of temsirolimus given as a 60-minute intravenous (IV) infusion once weekly to pediatric subjects with advanced solid tumors. Part 1 is an ascending-dose study to evaluate the safety of IV temsirolimus given once weekly to subjects ages 1 to 21 years with advanced solid tumors disease that is recurrent or refractory to standard therapy or for whom standard therapy is not available. (enrollment completed) Part 2 will be conducted in three groups of children with refractory or relapsed pediatric solid tumors. Subjects with the following tumor types will be enrolled: neuroblastoma, rhabdomyosarcoma, and high-grade gliomas. Subjects will receive IV temsirolimus once weekly until disease progression or unacceptable toxicity. (recruiting)
Detailed Description:
Keywords
Eligibility
Minimum Age: 1 Year
Eligible Ages: CHILD, ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Pfizer Investigational Site, Birmingham, Alabama, United States
Pfizer Investigational Site, San Francisco, California, United States
Pfizer Investigational Site, Chicago, Illinois, United States
Pfizer Investigational Site, Indianapolis, Indiana, United States
Pfizer Investigational Site, Boston, Massachusetts, United States
Pfizer Investigational Site, New York, New York, United States
Pfizer Investigational Site, New York, New York, United States
Pfizer Investigational Site, Philadelphia, Pennsylvania, United States
Pfizer Investigational Site, Philadelphia, Pennsylvania, United States
Pfizer Investigational Site, Greenville, South Carolina, United States
Pfizer Investigational Site, Memphis, Tennessee, United States
Pfizer Investigational Site, Houston, Texas, United States
Pfizer Investigational Site, Houston, Texas, United States
Pfizer Investigational Site, Seattle, Washington, United States
Pfizer Investigational Site, Calgary, Alberta, Canada
Pfizer Investigational Site, Edmonton, Alberta, Canada
Pfizer Investigational Site, Vancouver, British Columbia, Canada
Pfizer Investigational Site, Halifax,, Nova Scotia, Canada
Pfizer Investigational Site, London, Ontario, Canada
Pfizer Investigational Site, Toronto, Ontario, Canada
Pfizer Investigational Site, Paris Cedex 05, , France
Pfizer Investigational Site, Villejuif, , France
Pfizer Investigational Site, Muenster, , Germany
Pfizer Investigational Site, Mexico City, , Mexico
Pfizer Investigational Site, Lublin, , Poland
Pfizer Investigational Site, Lublin, , Poland
Pfizer Investigational Site, Warszawa, , Poland
Pfizer Investigational Site, Moscow, , Russian Federation
Pfizer Investigational Site, Moscow, , Russian Federation
Pfizer Investigational Site, Saint Petersburg, , Russian Federation
Contact Details
Name: Pfizer CT.gov Call Center
Affiliation: Pfizer
Role: STUDY_DIRECTOR
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