Lenalidomide in Treating Young Patients With Relapsed or Refractory Solid Tumors or Myelodysplastic Syndromes
Completed · Phase 1
Conditions studied: Childhood Myelodysplastic Syndromes, de Novo Myelodysplastic Syndromes, Previously Treated Myelodysplastic Syndromes, Refractory Anemia, Refractory Anemia With Excess Blasts, Refractory Anemia With Ringed Sideroblasts, Refractory Cytopenia With Multilineage Dysplasia, Secondary Myelodysplastic Syndromes, Unspecified Childhood Solid Tumor, Protocol Specific
In brief
This phase I trial is studying the side effects and best dose of lenalidomide in treating young patients with relapsed or refractory solid tumors or myelodysplastic syndromes. Lenalidomide may stop the growth of solid tumors or myelodysplastic syndromes by blocking blood flow to the cancer. It may also stimulate the immune system in different ways and stop cancer cells from growing.
Key facts
- Study ID
- NCT00104962
- Run by
- National Cancer Institute (NCI)
- People needed
- 24
- Starts
- 2005-03-01
- Expected to finish
- 2009-06-01
- Last updated by the study team
- 2014-06-11
Who can join
Age: 1 and older, up to 21. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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)
Where it is running
- COG Phase I Consortium — Arcadia, California, United States
Full record on ClinicalTrials.gov
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