Study Evaluating Biomarkers In Relapsed/Refractory Pediatric Solid Tumors

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

71

Participants

Timeline

Start Date

March 31, 2005

Primary Completion Date

October 31, 2009

Study Completion Date

January 31, 2012

Conditions
AdenocarcinomaNeoplasms
Interventions
DRUG

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.

Trial Locations (30)

10032

Pfizer Investigational Site, New York

11021

Pfizer Investigational Site, New York

19104

Pfizer Investigational Site, Philadelphia

29605

Pfizer Investigational Site, Greenville

35233

Pfizer Investigational Site, Birmingham

46202

Pfizer Investigational Site, Indianapolis

48149

Pfizer Investigational Site, Münster

60614

Pfizer Investigational Site, Chicago

75248

Pfizer Investigational Site, Paris

77030

Pfizer Investigational Site, Houston

94143

Pfizer Investigational Site, San Francisco

94805

Pfizer Investigational Site, Villejuif

98105

Pfizer Investigational Site, Seattle

115478

Pfizer Investigational Site, Moscow

117513

Pfizer Investigational Site, Moscow

197110

Pfizer Investigational Site, Saint Petersburg

02115

Pfizer Investigational Site, Boston

19104-4318

Pfizer Investigational Site, Philadelphia

38105-2794

Pfizer Investigational Site, Memphis

77030-2399

Pfizer Investigational Site, Houston

T3B 6A8

Pfizer Investigational Site, Calgary

T6G 2B7

Pfizer Investigational Site, Edmonton

V6H 3V4

Pfizer Investigational Site, Vancouver

B3K 6R8

Pfizer Investigational Site, Halifax

N6A 4G5

Pfizer Investigational Site, London

M5G 1X8

Pfizer Investigational Site, Toronto

04530

Pfizer Investigational Site, Mexico City

20- 093

Pfizer Investigational Site, Lublin

20-093

Pfizer Investigational Site, Lublin

04-730

Pfizer Investigational Site, Warsaw

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Pfizer

INDUSTRY