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

NCT ID: NCT00271063

Last Updated: 2007-12-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-10-31

Study Completion Date

2008-04-30

Brief Summary

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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

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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.

Conditions

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Acute Lymphocytic Leukemia

Keywords

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Refractory or Relapsed Acute Lymphocytic Leukemia

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Liposomal Annamycin

3-day IV infusion

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Callisto Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Callisto Pharmaceuticals

Principal Investigators

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Gary Jacob, PhD

Role: STUDY_DIRECTOR

Callisto Pharmaceuticals

Locations

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Roswell Park Cancer Institute

Buffalo, New York, United States

Site Status RECRUITING

Montefiore Medical Center

The Bronx, New York, United States

Site Status RECRUITING

MD Anderson Cancer Center

Houston, Texas, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Craig C. Talluto, PhD, abd

Role: CONTACT

Phone: 212-297-0010

Email: [email protected]

Facility Contacts

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Barbara Anderson, RN

Role: primary

Dominique Pinard, MS

Role: primary

Michelle Thomas, RN, BSN, OCN

Role: primary

Other Identifiers

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CP-103

Identifier Type: -

Identifier Source: org_study_id