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A Phase I/II Safety and Exploratory Pharmacogenomic/Pharmacodynamic Study of Intravenous Temsirolimus (CCI-779) in Pediatric Subjects With Relapsed/Refractory Solid Tumors


Phase 1/Phase 2
1 Year
21 Years
Not Enrolling
Both
Adenocarcinoma, Neoplasms

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Trial Information

A Phase I/II Safety and Exploratory Pharmacogenomic/Pharmacodynamic Study of Intravenous Temsirolimus (CCI-779) in Pediatric Subjects With Relapsed/Refractory Solid Tumors


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs): Part 1

Outcome Description:

An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.

Outcome Time Frame:

Baseline up to End of Treatment (EOT) (within 30 days of last dose)

Safety Issue:

Yes

Principal Investigator

Pfizer CT.gov Call Center

Investigator Role:

Study Director

Investigator Affiliation:

Pfizer

Authority:

United States: Food and Drug Administration

Study ID:

3066K1-139

NCT ID:

NCT00106353

Start Date:

March 2005

Completion Date:

January 2012

Related Keywords:

  • Adenocarcinoma
  • Neoplasms
  • Pediatric Tumors
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Neoplasms

Name

Location

Pfizer Investigational SiteBirmingham, Alabama  35205
Pfizer Investigational SiteBlendora, California  91740
Pfizer Investigational SiteSpringfield, Illinois  62701-1014
Pfizer Investigational SiteBronx, New York  10461
Pfizer Investigational SiteHouston, Texas  77030
Pfizer Investigational SiteFederal Way, Washington  98003
Pfizer Investigational SiteCarmel, Indiana  46032
Pfizer Investigational SiteNorth Adams, Massachusetts  01247
Pfizer Investigational SiteKingston, Pennsylvania  18704-5535
Pfizer Investigational SiteEasley,, South Carolina  29640
Pfizer Investigational SiteBristol, Tennessee  37620