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

Acute Lymphocytic Leukemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00271063
• Other study ID #: CP-103
• Status: Recruiting
• Phase: Phase 1/Phase 2
• First received: December 29, 2005
• Last updated: December 17, 2007
• Start date: October 2005
• Est. completion date: April 2008

Study information

• Verified date: December 2007
• Source: Callisto Pharmaceuticals
• Contact: Craig C. Talluto, PhD, abd
• Phone: 212-297-0010
• Email: ctalluto[@]callistopharma.com
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 34
• Est. completion date: April 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 15 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Lymphocytic Leukemia
• Leukemia
• Leukemia, Lymphoid
• Precursor Cell Lymphoblastic Leukemia-Lymphoma

Intervention

Drug:
• Liposomal Annamycin
3-day IV infusion

Locations

Country	Name	City	State
United States	Montefiore Medical Center	Bronx	New York
United States	Roswell Park Cancer Institute	Buffalo	New York
United States	MD Anderson Cancer Center	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Callisto Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate the safety and tolerability of L-Annamycin		8 months	Yes
Primary	MTD		8 months	Yes
Secondary	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	No
Secondary	To measure the pharmacokinetics of annamycin and its metabolite, annamycinol.		8 months	Yes