AZD2171 in Treating Young Patients With Recurrent, Progressive, or Refractory Primary CNS Tumors

Completed · Phase 1

Conditions studied: Childhood Atypical Teratoid/Rhabdoid Tumor, Childhood Central Nervous System Germ Cell Tumor, Childhood Cerebral Anaplastic Astrocytoma, Childhood Cerebral Astrocytoma, Childhood Grade I Meningioma, Childhood Grade II Meningioma, Childhood Grade III Meningioma, Childhood Infratentorial Ependymoma, Childhood Oligodendroglioma, Childhood Spinal Cord Neoplasm, Childhood Supratentorial Ependymoma, Recurrent Childhood Brain Neoplasm, Recurrent Childhood Brain Stem Glioma, Recurrent Childhood Cerebellar Astrocytoma, Recurrent Childhood Cerebral Astrocytoma, Recurrent Childhood Ependymoma, Recurrent Childhood Medulloblastoma, Recurrent Childhood Pineoblastoma, Recurrent Childhood Subependymal Giant Cell Astrocytoma, Recurrent Childhood Supratentorial Primitive Neuroectodermal Tumor, Recurrent Childhood Visual Pathway Glioma

In brief

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.

Key facts

Study ID

NCT00326664

Run by

National Cancer Institute (NCI)

People needed

55

Starts

2006-03-01

Expected to finish

2015-07-01

Last updated by the study team

2016-03-07

Who can join

Age: any, up to 21. Sex: any. Healthy volunteers: not accepted.

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
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• QTc prolongation =< 500 msec
• No other significant ECG abnormality within the past 14 days
• No clinically significant, unrelated, systemic illness, including serious infections or significant cardiac, pulmonary, hepatic, or other organ dysfunction, that would preclude study participation
• No uncontrolled hypertension
• Defined as systolic and diastolic BP > 95th percentile for age (ages 1-17)
• Defined as BP > 140/90 (ages 18 and older)
• No New York Heart Association class III or IV disease and Karnofsky/Lansky PS < 70

You may not qualify if…

• No known curative therapy available

Where it is running

• UCSF Medical Center-Mount Zion — San Francisco, California, United States
• Children's National Medical Center — Washington D.C., District of Columbia, United States
• Lurie Children's Hospital-Chicago — Chicago, Illinois, United States
• Dana-Farber/Harvard Cancer Center — Boston, Massachusetts, United States
• Duke University Medical Center — Durham, North Carolina, United States
• Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States
• Children's Hospital of Pittsburgh of UPMC — Pittsburgh, Pennsylvania, United States
• Pediatric Brain Tumor Consortium — Memphis, Tennessee, United States
• St. Jude Children's Research Hospital — Memphis, Tennessee, United States
• Texas Children's Hospital — Houston, Texas, United States
• Seattle Children's Hospital — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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