Lenalidomide in Treating Young Patients With Relapsed or Refractory Solid Tumors or Myelodysplastic Syndromes

Inclusion Criteria:

   - Diagnosis of 1 of the following:

      - Histologically confirmed solid tumor

         - No brain tumors

      - Myelodysplastic syndromes (MDS)

         - No refractory anemia with excess blasts in transformation or other forms of
         acute myeloid leukemia (AML)

         - No FAB diagnosis of refractory anemia with excess blasts in transition and
         other forms of AML

         - Newly diagnosed MDS with chromosome 5q abnormalities

   - Relapsed or refractory disease including relapse after stem cell transplantation

   - Measurable or evaluable disease (solid tumor patients only)

   - No known curative or life-prolonging therapy exists

   - No bone marrow involvement by tumor (solid tumor patients only)

   - No CNS tumors

   - Performance status - Karnofsky 50-100% (for patients > 10 years of age)

   - Performance status - Lansky 50-100% (for patients ≤ 10 years of age)

   - Absolute neutrophil count ≥ 1,000/mm^3 (for patients with solid tumors)

   - Platelet count ≥ 100,000/mm^3 (30,000 for patients with MDS)

      - Only patients with MDS may receive transfusions to support platelet counts

   - Hemoglobin ≥ 8.0 g/dL (transfusions allowed)

   - Bilirubin ≤ 1.5 times upper limit of normal (ULN)

   - ALT ≤ 110*

   - Albumin ≥ 2 g/dL

   - Creatinine clearance OR radioisotope glomerular filtration rate ≥ 70 mL/min

   - Creatinine based on age as follows:

      - Creatinine ≤ 0.8 mg/dL (for patients ≤ 5 years of age)

      - Creatinine ≤ 1 mg/dL (for patients 6 to 10 years of age)

      - Creatinine ≤ 1.2 mg/dL (for patients 11 to 15 years of age)

      - Creatinine ≤ 1.5 mg/dL (for patients over 15 years of age)

   - No parent or sibling with a known history of venous thrombosis before the age of 50 OR
   arterial thrombosis before the age of 40

   - No thromboembolic event except catheter-related thrombosis

   - Not pregnant or nursing

   - Negative pregnancy test

   - Fertile patients must use effective double-method contraception 4 weeks before,
   during, and for ≥ 4 weeks after completion of study treatment

   - Body surface area ≥ 0.4m^2

   - No uncontrolled infection

   - No active graft-vs-host disease from prior stem cell transplant or rescue

   - Recovered from prior immunotherapy

   - At least 1 week since prior biologic agents

   - At least 1 week since prior hematologic growth factors (2 weeks for pegfilgrastim)

   - At least 3 months since prior stem cell transplant or rescue (without total body
   irradiation [TBI])

   - Prior thalidomide allowed

   - No other concurrent immunotherapy

   - No other concurrent biologic therapy

   - More than 3 weeks since prior myelosuppressive chemotherapy (6 weeks for nitrosoureas)
   and recovered

   - No concurrent chemotherapy

   - Concurrent dexamethasone allowed provided the dose has been either decreasing or
   stable for the past 7 days

   - See Biologic therapy

   - Recovered from prior radiotherapy

   - At least 2 weeks since prior local palliative (small port) radiotherapy

   - At least 6 months since prior TBI, craniospinal radiotherapy, or radiotherapy to ≥ 50%
   of the pelvis

   - At least 6 weeks since other prior substantial bone marrow radiotherapy

   - No concurrent radiotherapy

   - No other concurrent investigational drugs or agents

   - No other concurrent anticancer agents