Study of Liposomal Annamycin in Patients With Refractory or Relapsed Acute Lymphocytic Leukemia - Full Text View

Sponsored by:	Callisto Pharmaceuticals
Information provided by:	Callisto Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00271063

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 I Phase II

MedlinePlus related topics: Cancer Leukemia, Adult Acute Leukemia, Adult Chronic Leukemia, Childhood

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Pharmacokinetics Study
Official Title:	Phase I/II Study of Liposomal Annamycin in Patients With Refractory or Relapsed Acute Lymphocytic Leukemia

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:

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

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
Roswell Park Cancer Institute	Recruiting
Buffalo, New York, United States, 14263
Contact: Barbara Anderson, RN 716-845-8360
Principal Investigator: Meir Wetzler, MD
Montefiore Medical Center	Recruiting
Bronx, New York, United States, 10467
Contact: Dominique Pinard, MS 718-920-2090
Principal Investigator: Samir Parekh, 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

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

Keywords provided by Callisto Pharmaceuticals:

Refractory or Relapsed Acute Lymphocytic Leukemia

Study placed in the following topic categories:

Lymphatic Diseases
Leukemia
Leukemia, Lymphoid
Annamycin

Immunoproliferative Disorders
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Lymphoproliferative Disorders
Lymphoma

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Histologic Type
Immune System Diseases
Antineoplastic Agents

Therapeutic Uses
Antibiotics, Antineoplastic
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009