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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00271063
Recruitment Status : Unknown
Verified December 2007 by Callisto Pharmaceuticals.
Recruitment status was:  Recruiting
First Posted : December 30, 2005
Last Update Posted : December 21, 2007
Information provided by:
Callisto Pharmaceuticals

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 Type : Interventional  (Clinical Trial)
Estimated 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 : October 2005
Estimated Study Completion Date : April 2008

Intervention Details:
    Drug: Liposomal Annamycin
    3-day IV infusion

Primary Outcome Measures :
  1. To evaluate the safety and tolerability of L-Annamycin [ Time Frame: 8 months ]
  2. MTD [ Time Frame: 8 months ]

Secondary Outcome Measures :
  1. 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 ]
  2. To measure the pharmacokinetics of annamycin and its metabolite, annamycinol. [ Time Frame: 8 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00271063

Contact: Craig C. Talluto, PhD, abd 212-297-0010 ext 231

United States, New York
Montefiore Medical Center Recruiting
Bronx, New York, United States, 10467
Contact: Dominique Pinard, MS    718-920-2090      
Principal Investigator: Samir Parekh, MD         
Roswell Park Cancer Institute Recruiting
Buffalo, New York, United States, 14263
Contact: Barbara Anderson, RN    716-845-8360      
Principal Investigator: Meir Wetzler, MD         
United States, Texas
MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Michelle Thomas, RN, BSN, OCN    713-763-8776      
Principal Investigator: Hagop Kantarjian, MD         
Sponsors and Collaborators
Callisto Pharmaceuticals
Study Director: Gary Jacob, PhD Callisto Pharmaceuticals

Responsible Party: Gary Jacob, Callisto Pharmaceuticals Identifier: NCT00271063     History of Changes
Other Study ID Numbers: CP-103
First Posted: December 30, 2005    Key Record Dates
Last Update Posted: December 21, 2007
Last Verified: December 2007

Keywords provided by Callisto Pharmaceuticals:
Refractory or Relapsed Acute Lymphocytic Leukemia

Additional relevant MeSH terms:
Leukemia, Lymphoid
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Antibiotics, Antineoplastic
Antineoplastic Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action