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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Phase I/II Study of Liposomal Annamycin in Patients With Refractory or Relapsed Acute Lymphocytic Leukemia

Conditions
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Acute Lymphocytic Leukemia

Intervention / Treatment
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* Drug: Liposomal Annamycin


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 15 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Liposomal Annamycin|3-day IV infusion|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the safety and tolerability of L-Annamycin |  | 8 months | 
| MTD |  | 8 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Refractory or Relapsed Acute Lymphocytic Leukemia