Aflibercept in Treating Young Patients With Relapsed or Refractory Solid Tumors

Completed · Phase 1

Conditions studied: Unspecified Childhood Solid Tumor, Protocol Specific

In brief

This phase I trial is studying the side effects and best dose of aflibercept in treating young patients with relapsed or refractory solid tumors. Aflibercept may stop the growth of tumor cells by blocking blood flow to the tumor.

Key facts

Study ID

NCT00622414

Run by

National Cancer Institute (NCI)

People needed

27

Starts

2008-04-01

Last updated by the study team

2014-02-24

Who can join

Age: 1 and older, up to 21. Sex: any. Healthy volunteers: not accepted.

You may qualify 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

Where it is running

• Lurie Children's Hospital-Chicago — Chicago, Illinois, United States
• Dana-Farber Cancer Institute — Boston, Massachusetts, United States
• Columbia University Medical Center — New York, New York, United States
• Oregon Health and Science University — Portland, Oregon, United States
• Baylor College of Medicine — Houston, Texas, United States
• Seattle Children's Hospital — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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