Study of Liposomal Annamycin in Patients With Refractory or Relapsed Acute Lymphocytic Leukemia
Phase I/II Study of Liposomal Annamycin in Patients With Refractory or Relapsed Acute Lymphocytic Leukemia
1 other identifier
interventional
34
1 country
3
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 with refractory or relapsed acute lymphocytic leukemia.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Oct 2005
Typical duration for phase_1
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2005
CompletedFirst Submitted
Initial submission to the registry
December 29, 2005
CompletedFirst Posted
Study publicly available on registry
December 30, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2008
CompletedDecember 21, 2007
December 1, 2007
December 29, 2005
December 17, 2007
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
To evaluate the safety and tolerability of L-Annamycin
8 months
MTD
8 months
Secondary Outcomes (2)
To study multi drug-resistant (MDR)-1 encoded P-170 glycoprotein expression and MDR-1 multidrug-resistant-associated protein (MRP), lung-resistance associated protein LRP), and breast cancer resistance protein (BCRP) mRNA levels
8 months
To measure the pharmacokinetics of annamycin and its metabolite, annamycinol.
8 months
Interventions
3-day IV infusion
Eligibility Criteria
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Roswell Park Cancer Institute
Buffalo, New York, 14263, United States
Montefiore Medical Center
The Bronx, New York, 10467, United States
MD Anderson Cancer Center
Houston, Texas, 77030, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Gary Jacob, PhD
Callisto Pharmaceuticals
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
December 29, 2005
First Posted
December 30, 2005
Study Start
October 1, 2005
Study Completion
April 1, 2008
Last Updated
December 21, 2007
Record last verified: 2007-12