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

Sponsor

Callisto Pharmaceuticals (Industry)

Overall Status

Unknown status

CT.gov ID

NCT00271063

Collaborator

(none)

Enrollment

Locations

Duration (Months)

11.3

Patients Per Site

0.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Acute Lymphocytic Leukemia	Drug: Liposomal Annamycin	Phase 1/Phase 2

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

34 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Oct 1, 2005

Anticipated Study Completion Date :

Apr 1, 2008

Outcome Measures

Primary Outcome Measures

To evaluate the safety and tolerability of L-Annamycin [8 months]
MTD [8 months]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

15 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Montefiore Medical Center	Bronx	New York	United States	10467
2	Roswell Park Cancer Institute	Buffalo	New York	United States	14263
3	MD Anderson Cancer Center	Houston	Texas	United States	77030