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

Status unconfirmed · Phase 1/Phase 2

Conditions studied: Acute Lymphocytic Leukemia

In brief

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.

Key facts

Study ID

NCT00271063

Run by

Callisto Pharmaceuticals

People needed

34

Starts

2005-10-01

Expected to finish

2008-04-01

Last updated by the study team

2007-12-21

Who can join

Age: 15 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Roswell Park Cancer Institute — Buffalo, New York, United States (enrolling)
• Montefiore Medical Center — The Bronx, New York, United States (enrolling)
• MD Anderson Cancer Center — Houston, Texas, United States (enrolling)

Full record on ClinicalTrials.gov

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