Status:
COMPLETED
Study Evaluating Biomarkers In Relapsed/Refractory Pediatric Solid Tumors
Lead Sponsor:
Pfizer
Conditions:
Adenocarcinoma
Neoplasms
Eligibility:
All Genders
1-21 years
Phase:
PHASE1
PHASE2
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...
Eligibility Criteria
Inclusion
- Part 1 only:
- \- 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
Key Trial Info
Start Date :
March 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2012
Estimated Enrollment :
71 Patients enrolled
Trial Details
Trial ID
NCT00106353
Start Date
March 1 2005
End Date
January 1 2012
Last Update
February 8 2013
Active Locations (30)
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1
Pfizer Investigational Site
Birmingham, Alabama, United States, 35233
2
Pfizer Investigational Site
San Francisco, California, United States, 94143
3
Pfizer Investigational Site
Chicago, Illinois, United States, 60614
4
Pfizer Investigational Site
Indianapolis, Indiana, United States, 46202