Study of Liposomal Annamycin in Patients With Refractory or Relapsed Acute Lymphocytic Leukemia
NCT ID: NCT00271063
Last Updated: 2007-12-21
Study Results
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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UNKNOWN
PHASE1/PHASE2
34 participants
INTERVENTIONAL
2005-10-31
2008-04-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Interventions
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Liposomal Annamycin
3-day IV infusion
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
15 Years
ALL
No
Sponsors
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Callisto Pharmaceuticals
INDUSTRY
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
Montefiore Medical Center
The Bronx, New York, United States
MD Anderson Cancer Center
Houston, Texas, United States
Countries
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Central Contacts
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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