Lenalidomide in Treating Young Patients With Relapsed or Refractory Solid Tumors or Myelodysplastic Syndromes
Childhood Myelodysplastic Syndromes, de Novo Myelodysplastic Syndromes, Previously Treated Myelodysplastic Syndromes
About this trial
This is an interventional treatment trial for Childhood Myelodysplastic Syndromes
Eligibility Criteria
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
Sites / Locations
- COG Phase I Consortium
Arms of the Study
Arm 1
Experimental
Treatment (lenalidomide)
Patients receive oral lenalidomide once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.