Study Evaluating Biomarkers In Relapsed/Refractory Pediatric Solid Tumors

Completed · Phase 1/Phase 2

Conditions studied: Adenocarcinoma, Neoplasms

In brief

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)

Key facts

Study ID

NCT00106353

Run by

Pfizer

People needed

71

Starts

2005-03-01

Expected to finish

2012-01-01

Last updated by the study team

2013-02-08

Who can join

Age: 1 and older, up to 21. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Inclusion Criteria:
• 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).

You may not qualify if…

• Exclusion Criteria:
• Subjects receiving enzyme-inducing anticonvulsants.
• Pulmonary hypertension or pneumonitis
• Active infection or serious intercurrent illness
• Other exclusions apply

Where it is running

• 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

Full record on ClinicalTrials.gov

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