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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2007 by Callisto Pharmaceuticals.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Callisto Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00271063
First received: December 29, 2005
Last updated: December 17, 2007
Last verified: December 2007
  Purpose

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 Intervention Phase
Acute Lymphocytic Leukemia
Drug: Liposomal Annamycin
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase I/II Study of Liposomal Annamycin in Patients With Refractory or Relapsed Acute Lymphocytic Leukemia

Resource links provided by NLM:


Further study details as provided by Callisto Pharmaceuticals:

Primary Outcome Measures:
  • To evaluate the safety and tolerability of L-Annamycin [ Time Frame: 8 months ] [ Designated as safety issue: Yes ]
  • MTD [ Time Frame: 8 months ] [ Designated as safety issue: Yes ]

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 [ Time Frame: 8 months ] [ Designated as safety issue: No ]
  • To measure the pharmacokinetics of annamycin and its metabolite, annamycinol. [ Time Frame: 8 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 34
Study Start Date: October 2005
Estimated Study Completion Date: April 2008
Intervention Details:
    Drug: Liposomal Annamycin
    3-day IV infusion
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.

  Eligibility

Ages Eligible for Study:   15 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00271063

Contacts
Contact: Craig C. Talluto, PhD, abd 212-297-0010 ext 231 ctalluto@callistopharma.com

Locations
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
Investigators
Study Director: Gary Jacob, PhD Callisto Pharmaceuticals
  More Information

No publications provided

Responsible Party: Gary Jacob, Callisto Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00271063     History of Changes
Other Study ID Numbers: CP-103
Study First Received: December 29, 2005
Last Updated: December 17, 2007
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Leukemia
Leukemia, Lymphoid
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Annamycin
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 24, 2014