Fenretinide in Children With Recurrent/Resistant ALL, AML, and NHL

• Status: Completed
• Trial end date: 2018-04-01
• Target enrollment: 0
• Participant gender: All

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 lymphoblastic leukemia (ALL), acute myelogenous leukemia (AML), and non-Hodgkin's lymphoma (NHL).

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: South Plains Oncology Consortium
• Treatments: Cytarabine; Fenretinide; Methotrexate; Retinamide

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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