Clinical trial NCT00271063: Study of Liposomal Annamycin in Patients With Refractory or Relapsed Acute Lymphocytic Leukemia
Official title: Phase I/II Study of Liposomal Annamycin in Patients With Refractory or Relapsed Acute Lymphocytic Leukemia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Acute Lymphocytic Leukemia
Keywords: Refractory or Relapsed Acute Lymphocytic Leukemia
Lead sponsor: Callisto Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2005-12-30
Enrollment: 34
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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 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.

Eligibility 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.

Primary outcomes:
measure: To evaluate the safety and tolerability of L-Annamycin
timeFrame: 8 months
measure: MTD
timeFrame: 8 months
Secondary outcomes:
measure: 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
timeFrame: 8 months
measure: To measure the pharmacokinetics of annamycin and its metabolite, annamycinol.
timeFrame: 8 months
Other outcomes:
Locations:
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: Buffalo
country: United States
facility: Roswell Park Cancer Institute
state: New York
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
Study officials:
affiliation: Callisto Pharmaceuticals
name: Gary Jacob, PhD
role: STUDY_DIRECTOR
References: