Status:
UNKNOWN
Study of Liposomal Annamycin in Patients With Refractory or Relapsed Acute Lymphocytic Leukemia
Lead Sponsor:
Callisto Pharmaceuticals
Conditions:
Acute Lymphocytic Leukemia
Eligibility:
All Genders
15+ years
Phase:
PHASE1
PHASE2
Brief 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 w...
Detailed 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 w...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2008
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT00271063
Start Date
October 1 2005
End Date
April 1 2008
Last Update
December 21 2007
Active Locations (3)
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1
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263
2
Montefiore Medical Center
The Bronx, New York, United States, 10467
3
MD Anderson Cancer Center
Houston, Texas, United States, 77030