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Investigator(s):
Elizabeth Fox, M.D. Principal Investigator Phone: 301-402-6641 foxb@mail.nih.gov
Referral Contact(s):
Pediatric Oncology  Phone: 1-877-624-4878 (Toll free)

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Primary Eligibility:

• Histologically confirmed malignancy at original diagnosis or relapse
• 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
• Recovered from prior therapy
• No prior aflibercept
• No concurrent anti-thrombotic or anti-platelet agents
• No concurrent medications known to inhibit platelet function or known to selectively inhibit cyclooxygenase-2 activity
• No other concurrent anticancer therapy
• ≥ 12 months and ≤ 21 years of age
• 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 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 (no platelet transfusions within 7 days prior to enrollment)
• Hemoglobin ≥ 8 g/dL (may receive RBC transfusions)



[Note: Patients with known bone marrow metastatic disease are eligible but not evaluated for hematologic toxicity; they also must not be known to be refractory to red cell or platelet transfusion]

• 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 normal age adjusted serum creatinine
• Bilirubin ≤ 1.5 x upper limit of normal (ULN) for age
• SEPT (ALT) ≤ 110 μ/L
• Serum albumin ≥ 2 g/dL
• PT/aPTT < 1.2 x ULN
• Diastolic blood pressure ≤ 95th percentile for age and gender and not receiving treatment for hypertension
• Not pregnant or nursing; fertile patients must use effective contraception
• No evidence of active graft-versus-host disease
• No history of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 4 weeks prior to Day 1 of study treatment
• No uncontrolled infection or serious or nonhealing wound, ulcer, or bone fracture
• No clinically significant cardiovascular disease within the past 6 months
• 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

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Treatment Plan:

This is a multicenter study.

Part 1:

• Patients receive aflibercept IV over 1 hour on Day 1
• Treatment repeats every 14 days for 2 years in the absence of disease progression or unacceptable toxicity
• Cohorts of 3–6 patients receive aflibercept until the maximum tolerated dose (MTD) is determined

Part 2:

• Patients receive aflibercept as in part 1 at 150% of the MTD determined in part 1
• Treatment repeats every 21 days for 2 years in the absence of disease progression or unacceptable toxicity

• Blood samples are collected prior to treatment on Day 1 of courses 1, 2, and 5 or 6
• After completion of study treatment, patients are followed for at least 30 days

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Additional Information:

• This trial will be conducted at the NIH Clinical Center in Bethesda, MD. It is open to patients who meet the eligibility requirements, regardless of where they live in the United States.
• There is no charge for medical care received at NIH Clinical Center.
• PDQ (Physicians Data Query) - provides additional details about this study for health care providers.

Reviewed: 11/12/08
Updated: 8/22/08