You are here

Study Evaluating Biomarkers In Relapsed/Refractory Pediatric Solid Tumors

Last updated on December 16, 2017

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Birmingham, Alabama, 35233 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Adenocarcinoma, Neoplasms
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
1-21 year
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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).

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

Exclusion Criteria:

- Subjects receiving enzyme-inducing anticonvulsants.

- Pulmonary hypertension or pneumonitis

- Active infection or serious intercurrent illness

- Other exclusions apply

NCT00106353
Pfizer
Completed
Study Evaluating Biomarkers In Relapsed/Refractory Pediatric Solid Tumors

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

call now

Try a new search

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your zip code, city, or country to find studies near you.

Similar Trials

Metastatic Pancreatic Ductal Adenocarcinoma
NCT02501902
All Genders
18+
Years
Multiple Sites
Breast Neoplasms
NCT01176916
Females
0+
Years
Multiple Sites
Breast Neoplasms, BRCA 1 Gene Mutation, BRCA 2 Gene Mutation
NCT01945775
All Genders
18+
Years
Multiple Sites
Breast Neoplasms, Stomach Neoplasms, Esophagogastric Junction Neoplasm, Non-small-cell Lung Carcinoma
NCT03284723
All Genders
18+
Years
Multiple Sites
Study Evaluating Biomarkers In Relapsed/Refractory Pediatric Solid Tumors
A Phase I/II Safety and Exploratory Pharmacogenomic/Pharmacodynamic Study of Intravenous Temsirolimus (CCI-779) in Pediatric Subjects With Relapsed/Refractory Solid Tumors

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)

Not Provided
Interventional
Phase 1
Phase 2
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Adenocarcinoma
  • Neoplasms
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.
Other Name: temsirolimus
Experimental: 1.0
Intervention: Drug: Torisel
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.


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
71
January 2012
October 2009   (Final data collection date for primary outcome measure)

Inclusion Criteria:

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).

Exclusion Criteria:

Exclusion Criteria:

  • Subjects receiving enzyme-inducing anticonvulsants.
  • Pulmonary hypertension or pneumonitis
  • Active infection or serious intercurrent illness
  • Other exclusions apply
Sexes Eligible for Study: All
1 Year to 21 Years   (Child, Adult)
No
Contact information is only displayed when the study is recruiting subjects
Canada,   France,   Germany,   Mexico,   Poland,   Russian Federation,   United States
 
 
NCT00106353
3066K1-139
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
January 2013

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]



Call Now