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

Primary Purpose

Acute Lymphocytic Leukemia

Status
Unknown status
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Liposomal Annamycin
Sponsored by
Callisto Pharmaceuticals
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Lymphocytic Leukemia focused on measuring Refractory or Relapsed Acute Lymphocytic Leukemia

Eligibility Criteria

15 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Montefiore Medical CenterRecruiting
  • Roswell Park Cancer InstituteRecruiting
  • MD Anderson Cancer CenterRecruiting

Outcomes

Primary Outcome Measures

To evaluate the safety and tolerability of L-Annamycin
MTD

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
To measure the pharmacokinetics of annamycin and its metabolite, annamycinol.

Full Information

First Posted
December 29, 2005
Last Updated
December 17, 2007
Sponsor
Callisto Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00271063
Brief Title
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

2. Study Status

Record Verification Date
December 2007
Overall Recruitment Status
Unknown status
Study Start Date
October 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
April 2008 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Callisto Pharmaceuticals

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Lymphocytic Leukemia
Keywords
Refractory or Relapsed Acute Lymphocytic Leukemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
34 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Liposomal Annamycin
Intervention Description
3-day IV infusion
Primary Outcome Measure Information:
Title
To evaluate the safety and tolerability of L-Annamycin
Time Frame
8 months
Title
MTD
Time Frame
8 months
Secondary Outcome Measure Information:
Title
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
Time Frame
8 months
Title
To measure the pharmacokinetics of annamycin and its metabolite, annamycinol.
Time Frame
8 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Craig C. Talluto, PhD, abd
Phone
212-297-0010
Ext
231
Email
ctalluto@callistopharma.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gary Jacob, PhD
Organizational Affiliation
Callisto Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Montefiore Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dominique Pinard, MS
Phone
718-920-2090
First Name & Middle Initial & Last Name & Degree
Samir Parekh, MD
Facility Name
Roswell Park Cancer Institute
City
Buffalo
State/Province
New York
ZIP/Postal Code
14263
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Barbara Anderson, RN
Phone
716-845-8360
First Name & Middle Initial & Last Name & Degree
Meir Wetzler, MD
Facility Name
MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michelle Thomas, RN, BSN, OCN
Phone
713-763-8776
First Name & Middle Initial & Last Name & Degree
Hagop Kantarjian, MD

12. IPD Sharing Statement

Learn more about this trial

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

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