Study of Liposomal Annamycin in Patients With Refractory or Relapsed Acute Lymphocytic Leukemia

This is a Phase I/II, multi-center, open-label, dose escalation, MTD study of liposomal
annamycin in refractory or relapsed ALL patients. Enrollment will occur in cohorts of
approximately 3 patients with 10 additional patients enrolled at the MTD. The liposomal
annamycin doses will be escalated in sequential cohorts. Four dose levels of liposomal
annamycin are planned: 190, 230, 280, and 310 mg/m2/day.

Inclusion Criteria:

- Diagnosis of refractory or relapsed ALL (acute lymphocytic leukemia)

- Age greater than or equal to 15 years

- No chemotherapy, radiation, or major surgery within 2 weeks prior to first dose of
study drug and recovered from toxic side effects of that therapy, unless treatment is
indicated due to progressive disease.

- No investigational therapy within 4 weeks of first dose of study drug

- ECOG performance status (PS) 0 to 2.

- Adequate liver function

- Adequate renal function

- Signed informed consent

Exclusion Criteria:

- Concommitant therapy that includes other chemotherapy that is or may be active
against ALL (except central nervous system [CNS] therapy)

- Any condition which in the opinion of the investigator, places the subject at
unacceptable risk if he/she were to participate in the study.

- Cardiac ejection fraction less than 40%

- Clinically relevant serious co-morbid medical conditions.

- Pregnant, lactating or not using adequate contraception.

- Known allergy to doxorubicin or anthracyclines.