Aflibercept in Treating Young Patients With Relapsed or Refractory Solid Tumors

You may be eligible if

• Histologically confirmed malignancy at original diagnosis or relapse (excluding intrinsic brain stem tumors, optic pathway gliomas, or patients with pineal tumors and elevations of serum alpha-fetoprotein of beta-HCG)
• * Patients with recurrent or refractory solid tumors are eligible, including primary CNS tumors or patients with known CNS metastases
• Current disease state must be one for which there is no known curative therapy or therapy proven to prolong survival with an acceptable quality of life
• Measurable or evaluable disease
• No evidence of CNS hemorrhage on baseline MRI for patients with known CNS disease
• Karnofsky performance status (PS) 50-100% (for patients \> 10 years of age) or Lansky PS 50-100% (for patients ≤ 10 years of age)
• * Neurologic deficits in patients with CNS tumors must have been relatively stable for a minimum of 1 week prior to study entry
• * Patients who are unable to walk because of paralysis, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score
• Patients with solid tumors without bone marrow involvement must meet the following criteria:
• * ANC ≥ 1,000/mm³
• * Platelet count ≥ 100,000/mm³ (transfusion independent, defined as not receiving platelet transfusions within a 7 day period prior to enrollment)
• * Hemoglobin ≥ 8.0 g/dL (may receive RBC transfusions)
• Negative protein dipstick OR urine protein \< 500 mg by 24-hour urine collection
• Creatinine clearance or radioisotope glomerular filtration rate ≥ 70 mL/min OR serum creatinine based on age/gender as follows:
• * 0.6 mg/dL for male and female patients 1 to \< 2 years of age
• * 0.8 mg/dL for male and female patients 2 to \< 6 years of age
• * 1.0 mg/dL for male and female patients 6 to \< 10 years of age
• * 1.2 mg/dL for male and female patients 10 to \< 13 years of age
• * 1.5 mg/dL (male) or 1.4 mg/dL (female) for patients 13 to \< 16 years of age
• * 1.7 mg/dL (male) or 1.4 mg/dL (female) for patients ≥ 16 years of age
• Bilirubin ≤ 1.5 times upper limit of normal (U.N.) for age
• SEPT (ALT) ≤ 110 μ/L (approx. 2.5 times U.N.) (for the purpose of this study, the U.N. for SEPT is 45 μ/L)
• Serum albumin ≥ 2 g/dL
• PT/aPTT \< 1.2 times U.N.
• Patients must have a diastolic blood pressure ≤ the 95th percentile for age and gender and not be receiving treatment for hypertension
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• No evidence of active graft-vs-host disease
• No uncontrolled infection
• No serious or nonhealing wound, ulcer, or bone fracture
• No history of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 4 weeks prior to day 1 of study treatment
• No clinically significant cardiovascular disease within the past 6 months, including any of the following:
• * History of cerebrovascular accident
• * New York Heart Association class III-IV congestive heart failure
• * Serious cardiac arrhythmia requiring medication
• * Unstable angina pectoris
• * Pulmonary embolism
• * Deep vein thrombosis
• * Other thromboembolic events
• No evidence of a current bleeding diathesis or coagulopathy
• No known hypersensitivity to Chinese hamster ovary cell products or other recombinant human antibodies
• No history of allergic reactions attributed to compounds of similar chemical or biologic composition to other agents used in the study
• No significant traumatic injury within 4 weeks prior to day 1 of study treatment
• Must be able to comply with the safety monitoring requirements of the study in the opinion of the investigator
• Recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy
• No prior aflibercept
• At least 3 weeks since prior myelosuppressive chemotherapy (6 weeks for nitrosourea)
• At least 6 weeks since prior monoclonal antibodies
• At least 2 weeks since prior local palliative radiotherapy (small port)
• At least 6 weeks since other prior substantial bone marrow radiotherapy
• At least 2 months since prior stem cell transplantation or rescue
• At least 3 months since prior total-body irradiation, craniospinal radiotherapy, or radiotherapy to ≥ 50% of the pelvis
• At least 4 weeks since prior major surgical procedure, laparoscopic procedure, or open biopsy and no anticipation of need for major surgical procedures during the course of the study
• At least 48 hours since prior fine needle aspirate, central line placement, or subcutaneous port placement
• At least 1 week since prior core biopsy
• At least 1 week since prior and no concurrent hematopoietic growth factors
• At least 1 week since prior and no concurrent biologic agents
• At least 1 week since prior and no concurrent dexamethasone
• No concurrent antihypertensive medications for blood pressure control
• No concurrent anti-thrombotic or anti-platelet agents (e.g., warfarin \[Coumadin ®\],heparin, low molecular weight heparin, aspirin, and/or ibuprofen, or other NSAIDs)
• No concurrent medications known to inhibit platelet function or known to selectively inhibit cyclooxygenase-2 activity (e.g., all antipyretic and anti-inflammatory medications except acetaminophen)
• No other concurrent anticancer therapy, including chemotherapy, radiotherapy, immunotherapy, or biologic therapy
• No other concurrent investigational drugs