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Study Evaluating Biomarkers In Relapsed/Refractory Pediatric Solid Tumors

Last updated on November 13, 2019

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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

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Descriptive Information
Brief Title  ICMJE Study Evaluating Biomarkers In Relapsed/Refractory Pediatric Solid Tumors
Official Title  ICMJE A Phase I/II Safety and Exploratory Pharmacogenomic/Pharmacodynamic Study of Intravenous Temsirolimus (CCI-779) in Pediatric Subjects With Relapsed/Refractory Solid Tumors
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 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)

Detailed DescriptionNot Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Adenocarcinoma
  • Neoplasms
Intervention  ICMJE 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
Study Arms  ICMJE Experimental: 1.0
Intervention: Drug: Torisel
Publications *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.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 10, 2010)
71
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE January 2012
Actual Primary Completion DateOctober 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 1 Year to 21 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   France,   Germany,   Mexico,   Poland,   Russian Federation,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00106353
Other Study ID Numbers  ICMJE 3066K1-139
Has Data Monitoring CommitteeNo
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyPfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateJanuary 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 the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

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Contact

[email protected]

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