FR901228 in Treating Children With Refractory or Recurrent Solid Tumors or Leukemia

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