NCT00326664

Brief Summary

This phase I trial is studying the side effects and best dose of AZD2171 in treating young patients with recurrent, progressive, or refractory primary CNS tumors. AZD2171 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
55

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Mar 2006

Longer than P75 for phase_1

Geographic Reach
1 country

11 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2006

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 16, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 17, 2006

Completed
9.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
Last Updated

March 7, 2016

Status Verified

March 1, 2016

Enrollment Period

9.3 years

First QC Date

May 16, 2006

Last Update Submit

March 4, 2016

Conditions

Childhood Atypical Teratoid/Rhabdoid TumorChildhood Central Nervous System Germ Cell TumorChildhood Cerebral Anaplastic AstrocytomaChildhood Cerebral AstrocytomaChildhood Grade I MeningiomaChildhood Grade II MeningiomaChildhood Grade III MeningiomaChildhood Infratentorial EpendymomaChildhood OligodendrogliomaChildhood Spinal Cord NeoplasmChildhood Supratentorial EpendymomaRecurrent Childhood Brain NeoplasmRecurrent Childhood Brain Stem GliomaRecurrent Childhood Cerebellar AstrocytomaRecurrent Childhood Cerebral AstrocytomaRecurrent Childhood EpendymomaRecurrent Childhood MedulloblastomaRecurrent Childhood PineoblastomaRecurrent Childhood Subependymal Giant Cell AstrocytomaRecurrent Childhood Supratentorial Primitive Neuroectodermal TumorRecurrent Childhood Visual Pathway Glioma

Outcome Measures

Primary Outcomes (1)

  • Maximum tolerated dose, defined as the dose at which the model estimates that 25% of patients will experience dose-limiting toxicity as measured by NCI CTCAE v4.0

    Estimated using the modified Continual Reassessment Method (CRM).

    42 days

Study Arms (1)

Treatment (cediranib maleate)

EXPERIMENTAL

Patients receive oral AZD2171 once daily on days 1-28. Treatment repeats every 28 days for up to 13 courses in the absence of disease progression or unacceptable toxicity.

Drug: Cediranib Maleate

Interventions

Cediranib MaleateDRUG

Given orally

Also known as: AZD2171, AZD2171 Maleate, Recentin
Treatment (cediranib maleate)

Eligibility Criteria

AgeUp to 21 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Histologically confirmed primary CNS tumor
  • Histologically benign brain tumors (e.g., low-grade glioma) allowed
  • Histological requirement waived for intrinsic brain stem or diffuse optic pathway tumors, but must have clinical and/or radiographic evidence of progression
  • Recurrent, progressive, or refractory disease
  • Absolute neutrophil count \>= 1,000/mm\^3 (unsupported)
  • Platelet count \>= 75,000/mm\^3 (unsupported)
  • Creatinine =\< 1.5 times upper limit of normal (ULN) OR glomerular filtration rate \>= 70 mL/min
  • Bilirubin =\< 1.5 times ULN
  • ALT =\< 2.5 times ULN
  • Urine dipstick or urinalysis \< 1+ protein
  • Albumin \>= 3 g/dL
  • Karnofsky performance status (PS) 60-100% (\> 16 years of age) OR Lansky PS 60-100% (=\< 16 years of age)
  • Karnofsky/Lansky PS 70-100% for patients at increased risk for compromised LVEF
  • Hemoglobin \>= 8 g/dL (transfusion support allowed)
  • No overt renal, hepatic, cardiac, or pulmonary disease
  • +29 more criteria

You may not qualify if:

  • No known curative therapy available

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

UCSF Medical Center-Mount Zion

San Francisco, California, 94115, United States

Location

Children's National Medical Center

Washington D.C., District of Columbia, 20010, United States

Location

Lurie Children's Hospital-Chicago

Chicago, Illinois, 60611, United States

Location

Dana-Farber/Harvard Cancer Center

Boston, Massachusetts, 02115, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

Children's Hospital of Pittsburgh of UPMC

Pittsburgh, Pennsylvania, 15224, United States

Location

Pediatric Brain Tumor Consortium

Memphis, Tennessee, 38105, United States

Location

St. Jude Children's Research Hospital

Memphis, Tennessee, 38105, United States

Location

Texas Children's Hospital

Houston, Texas, 77030, United States

Location

Seattle Children's Hospital

Seattle, Washington, 98105, United States

Location

MeSH Terms

Conditions

Rhabdoid TumorAstrocytomaOligodendrogliomaSpinal Cord NeoplasmsFamilial ependymomaMedulloblastomaOptic Nerve Glioma

Interventions

cediranib

Condition Hierarchy (Ancestors)

Neoplasms, Complex and MixedNeoplasms by Histologic TypeNeoplasmsGliomaNeoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms, Glandular and EpithelialNeoplasms, Nerve TissueCentral Nervous System NeoplasmsNervous System NeoplasmsNeoplasms by SiteSpinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesNeuroectodermal Tumors, PrimitiveOptic Nerve NeoplasmsCranial Nerve NeoplasmsPeripheral Nervous System NeoplasmsCranial Nerve DiseasesOptic Nerve DiseasesEye Diseases

Study Officials

  • Mark Kieran

    Pediatric Brain Tumor Consortium

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 16, 2006

First Posted

May 17, 2006

Study Start

March 1, 2006

Primary Completion

July 1, 2015

Study Completion

July 1, 2015

Last Updated

March 7, 2016

Record last verified: 2016-03

Locations

US(11)