Decitabine in Treating Children With Relapsed or Refractory Acute Myeloid Leukemia or Acute Lymphoblastic Leukemia

• Status: Terminated
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cancer Institute (NCI)
• Treatments: Azacitidine; Decitabine

Criteria

Inclusion Criteria:

• 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

• Concurrent seizure disorder allowed if well controlled on anticonvulsants

• No grade 2 or greater CNS toxicity

• No uncontrolled infection (i.e., infections associated with fever, dissemination, hemodynamic instability [requiring pressor support], and progression while on therapy)

• No active graft-versus-host disease (GVHD)

• GVHD well controlled on cyclosporine allowed

• Recovered from prior immunotherapy

• At least 1 week since prior biologic agents

• At least 6 months since prior allogeneic bone marrow transplantation (BMT)

• At least 3 months since prior autologous BMT

• No concurrent sargramostim (GM-CSF)

• No concurrent prophylactic filgrastim (G-CSF) during the first course of therapy

• Recovered from prior chemotherapy

• At least 4 weeks since prior cytarabine

• At least 24 hours since prior cytoreductive therapy with hydroxyurea (20-30 mg/kg/day for no more than 7 days) to lower the WBC to no greater than 30,000/mm^3

• No concurrent intrathecal therapy during the first course of decitabine

• Recovered from prior radiotherapy

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

• At least 6 weeks since prior cranial or craniospinal radiotherapy

• No concurrent medications that induce cytidine deaminase or deoxycytidine kinase (e.g., cytarabine)

• No concurrent medications that mask poor or deteriorating organ function

• No concurrent CNS prophylaxis during the first course of decitabine

• Concurrent anticonvulsants with no known interactions with decitabine allowed

• Concurrent antibacterial or antifungal therapies for controlled infections allowed