Phase I Study of CC-5013 (Lenalidomide NSC# 703813, IND # 70116) in Pediatric Patients With Relapsed/Refractory Solid Tumors or Myelodysplastic Syndrome

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