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Protocol Number: 05-C-0132 
A pediatric phase I trial of CC-5013 will be performed in children with recurrent or refractory tumors of the central nervous system, to determine the maximum tolerated dose (MTD) and safety profile of CC-5013 in this pediatric population. CC-5013 will be administered as capsules orally once a day for 21 days of a 28-day course. Primary Objectives: To estimate the MTD of oral CC-5013 administered to children with recurrent or refractory primary CNS tumors once daily for 21 days of a 28 day course. To describe the toxicity profile and define the dose-limiting toxicity of CC-5013 in children with recurrent or refractory primary CNS tumors. Secondary Objectives: To characterize the pharmacokinetics of CC-5013 in children and adolescents. To characterize the pharmacogenetics of CC-5013 in children and adolescents. To evaluate changes in circulating endothelial cells (CEC's) and circulating endothelial cell precursors (CEPs) in patients treated with CC-5013, and to investigate the correlation between changes in CECs and CEPs, plasma, serum and urine levels of proteins associated with angiogenesis including thrombospondin, b-FGF, TNF-a, IL-12, IL-8 and VEGF, and correlate these changes with changes in MR perfusion and clinical outcome. To evaluate changes in MR spectroscopy, MR perfusion and diffusion during treatment. Eligibility Criteria: Age: Patient must be less than or equal to 21 years of age. Tumor: Patients with a histological diagnosis of primary CNS tumor (including histologically benign brain tumors (e.g. low-grade glioma) that is recurrent, progressive, or refractory to standard therapy,. Patients with intrinsic brain stem or diffuse optic pathway tumors do not require histological confirmation of disease but should have clinical and/or radiographic evidence of progression. Performance Score: Karnofsky Performance Scale (KPS for greater than 16 yrs of age) or Lansky Performance Score (LPS for less than or equal to 16 years of age) greater than or equal to 60. Patient must be able to swallow capsules. Prior/ Concurrent Therapy. a. Patients must have no known curative therapy available. b. Patients must have recovered from any significant toxicity associated with prior therapy. patients will be eligible regardless of the number of prior therapies, as long as other eligibility criteria are met. c. Patients must have: received their last dose of known myelosuppressive anticancer chemotherapy or biological therapy at least three (3) weeks prior to study registration. received their last dose of nitrosourea or mitomycin-C at least six (6) weeks prior to study registration. received their last dose of other investigational agent or an anticancer drug known to not be myelosuppresive at least seven (7) days prior to study registration. d. XRT: Patients must have had their last fraction of craniospinal irradiation greater than or equal to 3 months prior to registration and their last fraction of local irradiation to primary tumor greater than or equal to 4 weeks prior to registration. e. Bone Marrow Transplant: Greater than or equal to 6 months since allogeneic bone marrow transplant and greater than or equal to 3 months since autologous bone marrow/stem cell transplant prior to registration. f. Growth factors: Off all colony forming growth factors(s) greater than 2 weeks prior to registration. Organ function: The following laboratory values must be assessed within two (2) weeks prior to registration and again within seven (7) days prior to the start of therapy. lab values should be repeated within 48 hours of therapy if the patient has undergone significant clinical change. a. Bone Marrow: Absolute neutrophil count greater than or equal to 1,000/microliter (unsupported); Platelets greater than or equal to 100,000/microliter (unsupported), Hemoglobin greater than or equal to 8.0 g/dL (may be supported). b. Renal: Serum creatinine within upper limit of institutional normal for age or GFR greater than or equal to 70 ml/min/1.73m(2). c. Hepatic: Bilirubin less than or equal to 1.5 times upper limit of normal for age; SGPT (ALT) less than 2.5 x institutional upper limit of normal for age and albumin greater than or equal to 2 g/dL. d. No overt renal, hepatic, cardiac o...
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National Institutes of Health Clinical Center