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

• Status: Unknown status
• Trial end date: 2008-04-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Callisto Pharmaceuticals
• Treatments: Annamycin; Doxorubicin

Criteria

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.