| Exclusion Criteria: | 1) Patients with locally advanced or metastatic solid tumors </=5 years from initial diagnosis are excluded. (Patients with locally advanced or metastatic solid tumors > 5 years from initial diagnosis, for whom the investigator has no clinical suspicion of active disease for >/=2 years before randomization are eligible).
2) Patients with t(16;16), inv(16) or t(8;21) or acute promyelocytic leukemia [t(15;17)].
3) Total lifetime anthracycline exposure exceeding the equivalent of 368 mg/m(2) of daunorubicin (or equivalent) prior to start of study therapy [(CPX-351 contains 44 mg/m(2) of DNR x 3 doses (1 induction)= 132 mg/m(2)] + 368 mg/m(2) = 500 mg/m(2)).
4) Any serious medical condition, laboratory abnormality or psychiatric illness that would prevent obtaining informed consent.
5) Administration of any antineoplastic therapy intended to treat first relapse. In the event of rapidly proliferative disease use of hydroxyurea is permitted until 24 hours before the start of study treatment.
6) Clinical evidence of active CNS leukemia.
7) Patients with history of and/or current evidence of myocardial impairment (e.g. cardiomyopathy, ischemic heart disease, significant valvular dysfunction, hypertensive heart disease, and congestive heart failure) resulting in New York Heart Association Class III or IV staging.
8) Active and uncontrolled infection. Patients with an infection receiving treatment with antibiotics may be entered into the study if they are afebrile and hemodynamically stable for >/=72 hrs.
9) Current evidence of invasive fungal infection (blood or tissue culture); HIV or active hepatitis C infection.
10) Hypersensitivity to cytarabine, daunorubicin or liposomal products.
11) History of Wilson's disease or other copper-related disorder.
12) Patients with a history of severe toxicity related to receiving conventional doses of cytarabine in first line treatment (approximately 100mg/m2/d for </= 7 days) are excluded. Patients who experienced unacceptable toxicity while receiving high dose cytarabine (approximately 3000mg/m2 for 6 doses) will not be treated again with the same regimen, but could be randomized to treatment with conventional dose cytarabine where the risk of major toxicity is less.
13) Women who are pregnant or breast feeding. |