Status:
TERMINATED
Fenretinide in Children With Recurrent/Resistant ALL, AML, and NHL
Lead Sponsor:
South Plains Oncology Consortium
Conditions:
Acute Myelogenous Leukemia
Acute Lymphoblastic Leukemia
Eligibility:
All Genders
Up to 21 years
Phase:
PHASE1
Brief Summary
The purposee of this study is to determine the safety and dosing of Fenretinide when given continuously for 5 days, every 3 weeks, in pediatric patients with recurrent and/or resistant acute lymphobla...
Detailed Description
Fenretinide is a cytotoxic retinoid that has activity against a variety of cell lines in vitro in a dose-related manner. The exact mechanism of fenretinide cytotoxicity in leukemia and lymphoma cell l...
Eligibility Criteria
Inclusion
- Diagnosed with relapsed or refractory ALL, AML, or NHL
- Must have had two or more therapeutic attempts for treating/curing disease
- Must have fully recoved from acute toxic effects of all prior therapy
- Karnofsky of greater than 50% for older than 10 years of age and Lansky greater than 50% for younger than 10 years.
Exclusion
- Grade 2 Pruritus or Rash (all forms)
- Grade 3 Dry Skin that is refractory to topical medical management
- Cardiac Fractional Shortening \< 27% on echocardiogram
- Left Ventricular Ejection Fraction \< 45% on echocardiogram
- Known allergy to egg products or soy bean oil
- Renal, Liver, and Pancreatic function:
- serum creatinine \> 1.5X ULN
- direct bilirubin \> 1.5X ULN
- ALT or AST \> 2.5X ULN
- Serum trigylcerides \> 2.5X ULN for age
- Lipase \> 1.5X ULN for age
- History of pancreatitis
Key Trial Info
Start Date :
August 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2018
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT01187810
Start Date
August 1 2010
End Date
April 1 2018
Last Update
March 31 2022
Active Locations (2)
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1
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States, 73104
2
MD Anderson Cancer Center
Houston, Texas, United States, 77030