Study Evaluating Biomarkers In Relapsed/Refractory Pediatric Solid Tumors
NCT ID: NCT00106353
Last Updated: 2013-02-08
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1/PHASE2
71 participants
INTERVENTIONAL
2005-03-31
2012-01-31
Brief Summary
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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)
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Detailed Description
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Conditions
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Study Design
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PARALLEL
TREATMENT
NONE
Study Groups
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1.0
Torisel
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.
Interventions
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Torisel
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
\- Subjects with a histological diagnosis of advanced cancer (solid tumors or central nervous system \[CNS\] tumors) with disease that is recurrent or refractory to standard therapy or for whom standard therapy is not available (histological confirmation waived for brain stem gliomas and optic pathway tumors)
Part 2 only:
* Subjects with histologically confirmed diagnosis of refractory or relapsed: Neuroblastoma, High-grade gliomas: glioblastoma multiforme, anaplastic astrocytomas, and other high-grade gliomas (histological confirmation waived for brain stem gliomas), Rhabdomyosarcoma.
* Measurable disease (for subjects with neuroblastoma, evaluable disease as determined by a positive metaiodobenzylguanidine (MIBG) scan will also be permitted).
Exclusion Criteria
* Pulmonary hypertension or pneumonitis
* Active infection or serious intercurrent illness
* Other exclusions apply
1 Year
21 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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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, , France
Pfizer Investigational Site
Villejuif, , France
Pfizer Investigational Site
Münster, , Germany
Pfizer Investigational Site
Mexico City, Mexico City, Mexico
Pfizer Investigational Site
Lublin, , Poland
Pfizer Investigational Site
Lublin, , Poland
Pfizer Investigational Site
Warsaw, , Poland
Pfizer Investigational Site
Moscow, , Russia
Pfizer Investigational Site
Moscow, , Russia
Pfizer Investigational Site
Saint Petersburg, , Russia
Countries
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References
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Geoerger B, Kieran MW, Grupp S, Perek D, Clancy J, Krygowski M, Ananthakrishnan R, Boni JP, Berkenblit A, Spunt SL. Phase II trial of temsirolimus in children with high-grade glioma, neuroblastoma and rhabdomyosarcoma. Eur J Cancer. 2012 Jan;48(2):253-62. doi: 10.1016/j.ejca.2011.09.021. Epub 2011 Oct 25.
Other Identifiers
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3066K1-139
Identifier Type: -
Identifier Source: org_study_id
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