a. 12 months to 21 years at time of enrollment into dose
b. 12 months to 30 years at time of enrollment into
Diagnosis: Patients must have a diagnosis of a hematologic malignancy
(acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL), or
a. Acute myeloid leukemia - patients with non-therapy
related AML must be in first or greater relapse or have refractory disease to
at least two courses of induction therapy.
b. Acute lymphoid leukemia - patients with ALL must be in
second or greater relapse or have relapsed disease refractory to re-induction
c. Aggressive Lymphoma - patients must have relapsed or
refractory disease for which there is no known curative therapy available.
Patients must have measurable disease by CT scan.
Performance status: Karnofsky > or = to 50% or Lansky > or = to 50.
Prior therapy: Patients must have fully recovered from acute toxicities of
a. Hematopoetic Stem cell transplant (HSCT): Patients who
relapsed after HSCT, are eligible provided they have no evidence of active
graft versus host disease (GVHD) and are at least 2 months post-transplant.
b. Anthracycline exposure: Patients who have not
previously had TBI (total body irradiation) must have a total previous
cumulative anthracycline exposure ≤ 450 mg/m2 daunorubicin equivalents.
Patients who have had prior TBI or radiation to the mediastinum must have a
previous cumulative anthracycline exposure e ≤ 300 mg/m2 daunorubicin
a. AML and Lymphoma: at least 14 days must have elapsed
since the completion of systemic cytotoxic therapy, with the exception of
b. ALL: patients who relapsed while receiving standard
maintenance therapy do not have a waiting period. At least 14 days must have
elapsed since receiving systemic cytarabine or an
c. Intrathecal cytotoxic therapy: no waiting period is
required for patients receiving intrathecal cytarabine, methotrexate and/or
hydrocortisone. At least 14 days must have elapsed since receiving liposomal
cytarabine in intrathecal injection.
Organ function requirements
a. Adequate bone marrow function - platelet count >/=
20,000/uL (may receive platelet transfusions; Hemoglobin >/= 8 g/dL (may
receive red blood cell transfusions)
b. Adequate Renal function - a maximum serum creatinine
is based on age/gender. Subjects that do not meet eligibility criteria based
upon serum creatinine may meet eligibility criteria based upon a 24 hour
creatinine clearance or radioisotope determined GFR >/= 70 mL/min/1.73 m2.
c. Adequate liver function - Direct bilirubin </= 1.5
x upper limit of normal (ULN) for age and SGPT (ALT) < 5.0 x upper limit of
normal (ULN) for age and institution (unless elevation is related to leukemia
d. Adequate cardiac function - Shortening fraction of
>/= 27% by echocardiogram, or Ejection fraction of >/= 50% by gated
radionuclide study or echocardiogram.
e. Central Nervous system function - patients with
seizure disorder may be enrolled if on anticonvulsants and well controlled and
CNS toxicity </= Grade 2.
•Patients with the following diagnosis are not eligible: acute
promyelocytic leukemia (APML), Down Syndrome, Fanconi Anemia, acute
lymphoblastic leukemia with central nervous system leukemia (CNS status 3),
•Pregnant or breast-feeding women. Males and females of reproductive potential
may not participate unless they have agreed to use an effective method of
a. Growth factors- growth factors that support platelet
or white cell number or function must not be administered within 7 days prior
b. Investigational drugs - patients currently receiving
another Investigational drug are not eligible.
c. Anti-cancer agents- patients who are currently
receiving other anti-cancer agents are not eligible with the exception of
intrathecal cytarabine and oral hydroxyurea. Hydroxyurea must be discontinued
24 hours prior to initiation of protocol therapy.
•Infection: Patients who have an uncontrolled infection are not eligible.
•Patients who in the opinion of the investigator may not be able to comply
with the safety monitoring requirements of the study are not eligible.
•History of Wilson's disease or other copper-metabolism disorder
•Major surgery within 4 weeks of enrollment.
•Greater than 13.6 Gy prior radiation to the mediastinum