Status:
TERMINATED
Liposomal Annamycin in Children and Young Adults With Refractory or Relapsed ALL or AML
Lead Sponsor:
Callisto Pharmaceuticals
Conditions:
Acute Lymphocytic Leukemia
Acute Myelogenous Leukemia
Eligibility:
All Genders
12-21 years
Phase:
PHASE1
Brief Summary
This is a Phase I, multi-center, open-label, dose escalation, MTD study of liposomal annamycin in children and young adults with refractory or relapsed ALL or AML. Enrollment will occur in cohorts of ...
Detailed Description
This is a Phase I, multi-center, open-label, dose escalation, MTD study of liposomal annamycin in children and young adults with refractory or relapsed ALL or AML. Enrollment will occur in cohorts of ...
Eligibility Criteria
Inclusion
- Diagnosis of refractory or relapsed ALL or AML.
- 12 months to 21 years of age at the time of informed consent.
- Weight ≥10 kg
- No chemotherapy, radiation, or major surgery within 2 weeks prior to first dose of study drug and recovered from the toxic side effects of such therapy. In the instance of rapidly progressive disease, anti-leukemia therapy may be administered within the 2-week period as long as the subject has recovered from the toxic effects of that therapy. Also, intrathecal therapy may be administered within the 2-week period for subjects with CNS disease.
- No stem cell transplant regimen within 3 months prior to first dose of study drug.
- No conventional granulocyte colony stimulating factor (G-CSF) within 7 days prior to the first dose of study drug, and no long-acting G-CSF (Neulasta) within 14 days prior to the first dose of study drug.
- No investigational therapy within 4 weeks prior to first dose of study drug.
- Karnofsky Performance Status ≥50% for subjects ≥10 years of age and Lansky Performance Status ≥60% for subjects \<10 years of age. Subjects who are unable to walk because of paralysis, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance status.
- Adequate liver function \[bilirubin ≤2 times the upper limit of normal (ULN) and serum glutamic-pyruvic transaminase (SGPT) ≤5 times the ULN\].
- Adequate renal function (creatinine clearance ≥60 ml/min/1.73m2).
- Adequate cardiac function \[ejection fraction (EF) \>50% or shortening fraction (SF) \>28% by echocardiogram or MUGA\]
- Informed consent signed by subject or legal guardian per investigational site guidelines.
- Able to comply with the requirements of the protocol.
- Females of childbearing potential must have a negative serum or urine pregnancy test within 72 hours prior to first dose of study drug.
- All subjects (male and female) of childbearing potential must agree to practice effective contraception during the entire study period, unless documentation of infertility exists. Should a female become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
Exclusion
- Concomitant therapy that includes other chemotherapy that is or may be active against ALL or AML, except for prophylaxis and/or treatment of opportunistic or other infection with antibiotics, antifungals and/or antiviral agents. Concurrent radiation therapy and immunosuppressive therapy are not allowed. Concurrent intrathecal therapy per standard of care is allowed for subjects with CNS disease.
- Any condition which, in the opinion of the Investigator, places the subject at unacceptable risk if he/she were to participate in the study.
- Clinically relevant serious co-morbid medical conditions including, but not limited to, active infection, recent (≤6 months) myocardial infarction, unstable angina, symptomatic congestive heart failure, uncontrolled hypertension, uncontrolled cardiac arrhythmias, chronic obstructive or chronic restrictive pulmonary disease, and cirrhosis, or psychiatric illness/social situations that would limit compliance with study requirements. Cardiac patients with a New York Heart Association (NYHA) classification of 3 or 4 will be excluded.
- Active graft-versus-host disease (GVHD).
- Pregnant, lactating, or not using adequate contraception.
- Known allergy to doxorubicin or anthracyclines.
- Any evidence of mucositis/stomatitis, except for Grade 1 mucositis/stomatitis due to chronic GVHD.
Key Trial Info
Start Date :
February 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2009
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT00430443
Start Date
February 1 2007
End Date
January 1 2009
Last Update
August 31 2011
Active Locations (3)
Enter a location and click search to find clinical trials sorted by distance.
1
Phoenix Children's Hospital
Phoenix, Arizona, United States, 85016
2
Denver Children's Hospital
Denver, Colorado, United States, 80218
3
Vanderbilt Children's Hospital
Nashville, Tennessee, United States, 37237