AZD2171 in Treating Young Patients With Recurrent, Progressive, or Refractory Primary CNS Tumors
Childhood Atypical Teratoid/Rhabdoid Tumor, Childhood Central Nervous System Germ Cell Tumor, Childhood Cerebral Anaplastic Astrocytoma
About this trial
This is an interventional treatment trial for Childhood Atypical Teratoid/Rhabdoid Tumor
Eligibility Criteria
Inclusion Criteria: 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 Class II disease controlled with treatment and increased monitoring is allowed Recovered from all prior therapy No prior AZD2171 At least 3 weeks since prior myelosuppressive anticancer chemotherapy (6 weeks for nitrosoureas) More than 1 weeks since prior investigational or biologic agents If the investigational or biologic agent has a prolonged half-life (> 48 hours), then these patients must be discussed with the study chair prior to registration No concurrent drugs or biologics with proarrhythmic potential More than 3 months since last fraction of craniospinal radiotherapy or total-body irradiation More than 4 weeks since last fraction of focal irradiation to symptomatic metastatic sites At least 6 months since prior allogeneic bone marrow transplantation At least 3 months since prior autologous bone marrow or stem cell transplantation At least 1 week since prior filgrastim (G-CSF), sargramostim (GM-CSF), or epoetin alfa (2 weeks for pegfilgrastim) No other concurrent investigational agents Concurrent dexamethasone allowed provided patient is on a stable or decreasing dose for ≥ 1 week before study entry No concurrent chemotherapy No concurrent routine use of G-CSF, GM-CSF, or epoetin alfa Able to swallow tablets Any neurologic deficits must be stable for >= 1 week If the investigational or biologic agent has a prolonged half-life (> 48 hours), then these patients must be discussed with the study chair prior to registration Exclusion Criteria: No known curative therapy available
Sites / Locations
- UCSF Medical Center-Mount Zion
- Children's National Medical Center
- Lurie Children's Hospital-Chicago
- Dana-Farber/Harvard Cancer Center
- Duke University Medical Center
- Children's Hospital of Philadelphia
- Children's Hospital of Pittsburgh of UPMC
- Pediatric Brain Tumor Consortium
- St. Jude Children's Research Hospital
- Texas Children's Hospital
- Seattle Children's Hospital
Arms of the Study
Arm 1
Experimental
Treatment (cediranib maleate)
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.