FR901228 in Treating Children With Refractory or Recurrent Solid Tumors or Leukemia
Blastic Phase Chronic Myelogenous Leukemia, Childhood Central Nervous System Germ Cell Tumor, Childhood Choroid Plexus Tumor
About this trial
This is an interventional treatment trial for Blastic Phase Chronic Myelogenous Leukemia
Eligibility Criteria
Inclusion Criteria: Histologically confirmed malignancy Extracranial solid tumors or brain tumors* Diagnosis of leukemia allowed after maximum tolerated dose is determined, including any of the following: Acute lymphoblastic leukemia Acute myelogenous leukemia Chronic myelogenous leukemia in blast crisis Disease must be refractory to conventional therapy or no effective conventional therapy exists CNS tumors resulting in neurological deficits must be stable for 2 weeks before study entry Performance status - Karnofsky 60-100% (over 10 years old) Performance status - Lansky 60-100% (10 years old and under) At least 8 weeks Absolute neutrophil count at least 1,000/mm^3 (for solid tumor patients without bone marrow involvement) Platelet count at least 100,000/mm^3 (for solid tumor patients without bone marrow involvement; platelet transfusion independent) OR 20,000/mm^3 (for leukemia patients; platelet transfusion allowed) Hemoglobin at least 8.0 g/dL (RBC transfusions allowed) Bilirubin no greater than 1.5 times upper limit of normal (ULN) ALT no greater than 5 times ULN Albumin at least 2 g/dL Glomerular filtration rate at least 70 mL/min Creatinine based on age as follows: No greater than 0.8 mg/dL (for patients 5 years of age and under) No greater than 1.0 mg/dL (for patients 6 to 10 years of age) No greater than 1.2 mg/dL (for patients 11 to 15 years of age) No greater than 1.5 mg/dL (for patients over 15 years of age) Calcium normal (with or without supplementation) Shortening fraction at least 27% by echocardiogram OR ejection fraction at least 50% by MUGA No symptomatic congestive heart failure No uncontrolled cardiac arrhythmia QTc less than 450 msec No evidence of dyspnea at rest No exercise intolerance Pulse oximetry greater than 94% Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for 1 month after completion of study treatment Magnesium and potassium normal (with or without supplementation) No uncontrolled seizure disorder No uncontrolled infection No graft-vs-host disease No seizure disorder unless well controlled and not on enzyme-inducing anticonvulsants At least 1 week since prior growth factors At least 3 weeks since prior biologic therapy or immunotherapy and recovered At least 6 months since prior allogeneic stem cell transplantation No concurrent routine prophylactic growth factors At least 3 weeks since prior myelosuppressive chemotherapy (4 weeks for nitrosoureas) and recovered No prior FR901228 (depsipeptide) No other concurrent anticancer chemotherapy Concurrent dexamethasone for CNS tumors allowed if on stable dose or decreasing dose for at least 1 week before study entry Recovered from prior radiotherapy At least 2 weeks since prior local palliative radiotherapy (small port) At least 6 months since prior craniospinal radiotherapy or radiotherapy to at least 50% of pelvis At least 6 weeks since other prior substantial bone marrow radiation More than a 5 half-life washout period since prior and no concurrent medications associated with prolongation of QTc interval No concurrent enzyme-inducing anticonvulsants No concurrent hydrochlorothiazide No other concurrent investigational drugs
Sites / Locations
- Children's Oncology Group
Arms of the Study
Arm 1
Experimental
Arm I
Patients receive FR901228 (depsipeptide) IV over 4 hours on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.