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

Callisto Pharmaceuticals

Status and phase

Unknown

Phase 2

Phase 1

Conditions

Acute Lymphocytic Leukemia

Treatments

Drug: Liposomal Annamycin

Study type

Interventional

Funder types

Industry

Identifiers

NCT00271063

CP-103

Details and patient eligibility

About

This is a Phase I/II multi-center, open label, dose escalation study to identify the maximum tolerated dose (MTD) of liposomal annamycin and to evaluate the safety of liposomal annamycin in patients with refractory or relapsed acute lymphocytic leukemia.

Full description

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.

Enrollment

34 estimated patients

Sex

All

Ages

15+ years old

Volunteers

No Healthy Volunteers

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.