Clinical Trial Finder

Inclusion Criteria:

• - Patients with a histological diagnosis of a 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.

• - Karnofsky Performance Scale (KPS for >= 16 yrs of age) or Lansky Performance Score (LPS for ≤ 16 years of age) ≥ 60 assessed within two weeks prior to registration.

• - Patient must be able to swallow capsules.

• - Patients must have recovered from any significant acute toxicity associated with prior therapy; patients must have no known curative therapy available; patients will be eligible regardless of the number of prior therapies, as long as other eligibility criteria are met.

• - Chemo: Prior use of thalidomide is acceptable; 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 myelosuppressive at least seven (7) days prior to study registration.

• - XRT: Patients must have had their last fraction of craniospinal irradiation ≥ 3 months prior to registration and their last fraction of local irradiation to primary tumor ≥ 4 weeks prior to registration.

• - Bone Marrow Transplant: ≥ 6 months since allogeneic bone marrow transplant and ≥ 3 months since autologous bone marrow/stem cell prior to registration.

• - Growth factors: Off all colony forming growth factor(s) > 2 weeks prior to registration (filgrastim, sargramostim, erythropoietin) - 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; laboratory tests should be repeated within 48 hours of beginning therapy if there has been a significant clinical change.

• - Absolute neutrophil count ≥ 1000/μl (unsupported) - Platelets ≥ 100,000/μl (unsupported) - Hemoglobin ≥ 8.0 g/dL (may be supported) - Serum creatinine within upper limit of institutional normal for age.

• - Or GFR ≥ 70 ml/min/1.73m^2.

• - Bilirubin ≤ 1.5 times upper limit of normal for age.

• - SGPT (ALT) ≤ 2.5x institutional upper limit of normal for age.

• - Albumin ≥ 2 g/dL.

• - No overt renal, hepatic, cardiac or pulmonary disease.

• - Female patients of childbearing potential must have negative serum or urine pregnancy test (sensitivity of at least 50mIU/ml); patients must not be pregnant or breast-feeding.

• - All sexually active females must begin 2 methods of birth control, including 1 highly effective method, and 1 additional method (at the same time) at least 4 weeks prior to the first dose of CC-5013; this applies to all sexually active females of childbearing potential unless they have not had a menstrual period in 2 years or have undergone a hysterectomy.

• - Patients of child fathering potential must agree to use latex condoms during intercourse with a woman while taking CC-5013 and for 4 weeks thereafter.

• - Signed informed consent according to institutional guidelines must be obtained.

Exclusion Criteria:

• - Patients with a body surface area (BSA) ≤ 0.4 m^2 are excluded.

• - Patients with a first-degree relative with a history of venous thrombosis before age 50 yrs or an arterial thrombosis before age 40 yrs are excluded.

• - Patients who have had a thromboembolic event that is not line-related are excluded.

• - Patients with any significant medical illnesses that, in the investigator's opinion, cannot be adequately controlled with appropriate therapy or would compromise a patient's ability to tolerate this therapy.

• - Patients with any disease that would obscure toxicity or dangerously alter drug metabolism.

• - Patients receiving any other chemotherapeutics or investigational agents.

• - Patients with uncontrolled infection.

• - Patients unable to swallow capsules.

- Patients with known hypersensitivity to anhydrous lactose, microcrystalline cellulose, croscarmellose sodium, and magnesium stearate

PRIMARY OBJECTIVES:

• I. 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.

• II. 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:

• I. To characterize the pharmacokinetics of CC-5013 in children and adolescents.

• II. To characterize the pharmacogenetics of CC-5013 in children and adolescents.

• III. To evaluate changes in circulating endothelial cells (CECs) 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-α, IL-12, IL-8 and VEGF, and correlate these changes with changes in MR perfusion and clinical outcome.

• IV. To evaluate changes in MR perfusion and diffusion during treatment.

OUTLINE: This is a dose-escalation, multicenter study. Patients receive oral lenalidomide once daily on days 1-21. Treatment repeats every 28 days for 24 courses in the absence of disease progression or unacceptable toxicity. Cohorts of 2-3 patients receive escalating doses of lenalidomide until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which an estimated 25% of patients experience dose-limiting toxicity. All patients are followed for at least 30 days after the last dose of lenalidomide. Patients with treatment-related toxicity are followed for up to 3 months.

Arms

Experimental: Treatment (lenalidomide)

Patients receive oral lenalidomide once daily on days 1-21. Treatment repeats every 28 days for 24 courses in the absence of disease progression or unacceptable toxicity. Cohorts of 2-3 patients receive escalating doses of lenalidomide until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which an estimated 25% of patients experience dose-limiting toxicity.

Interventions

Drug: - lenalidomide

Given PO

Procedure: - perfusion-weighted magnetic resonance imaging

Correlative studies

Procedure: - diffusion-weighted magnetic resonance imaging

Correlative studies

Other: - laboratory biomarker analysis

Correlative studies