Decitabine in Treating Children With Relapsed or Refractory Acute Myeloid Leukemia or Acute Lymphoblastic Leukemia
Stopped early · Phase 1
Conditions studied: Childhood Acute Myeloblastic Leukemia With Maturation (M2), Childhood Acute Promyelocytic Leukemia (M3), Recurrent Childhood Acute Lymphoblastic Leukemia, Recurrent Childhood Acute Myeloid Leukemia, Secondary Acute Myeloid Leukemia
In brief
Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. This phase I trial is studying the side effects and best dose of decitabine in treating children with relapsed or refractory acute myeloid leukemia or acute lymphoblastic leukemia
Key facts
- Study ID
- NCT00042796
- Run by
- National Cancer Institute (NCI)
- People needed
- 21
- Starts
- 2002-12-01
- Last updated by the study team
- 2013-01-23
Who can join
Age: any, up to 21. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Histologically confirmed acute myeloid leukemia (AML) or acute lymphoblastic leukemia that is considered refractory to conventional therapy or for which no conventional therapy exists
- For patients with AML:
- M3 marrow
- M2 marrow with at least 15% blasts
- Secondary AML allowed
- CNS involvement allowed
- Performance status - Karnofsky 50-100% (age 17 to 21)
- Performance status - Lansky 50-100% (age 16 and under)
- At least 8 weeks
- See Chemotherapy
- WBC no greater than 30,000/mm\^3
- Patients with granulocytopenia, anemia, and/or thrombocytopenia are eligible but are not evaluable for hematological toxicity
- Bilirubin no greater than 1.5 times normal
- ALT no greater than 5 times normal
- Albumin at least 2 g/dL
- Creatinine no greater than 1.5 times normal
- Creatinine clearance or radioisotope glomerular filtration rate at least lower limit of normal
- Shortening fraction at least 27% by echocardiogram
- Ejection fraction at least 50% by MUGA scan
- No evidence of dyspnea at rest
- No exercise intolerance
- Oxygen saturation greater than 94% by pulse oximetry
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
Where it is running
- Children's Oncology Group — Arcadia, California, United States
Full record on ClinicalTrials.gov
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