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

South Plains Oncology Consortium

Status and phase

Terminated

Phase 1

Conditions

Acute Myelogenous Leukemia

Non-Hodgkin's Lymphoma

Acute Lymphoblastic Leukemia

Treatments

Drug: Fenretinide

Drug: Methotrexate

Drug: Cytarabine

Study type

Interventional

Funder types

NETWORK

Identifiers

NCT01187810

SPOC2008-01

Details and patient eligibility

About

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).

Full 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 lines is not known, but may include the de novo ceramide synthesis of ceramides and the generation of reactive oxygen species. The malignancy-specific nature of fenretinide-induced ceramides suggests that combinations of the drug with other ceramide modulating agents may have a favorable therapeutic index.

In this study, the primary aims are to define the maximum tolerated dose, toxicity profile, and pharmacokinetics of IV fenretinide when given continuously in pediatric patients with ALL, AML, and NHL. The drug will be administered via a central venous or percutaneous indwelling central catheter in an inpatient hospital setting.

Enrollment

3 patients

Sex

All

Ages

Under 21 years old

Volunteers

No Healthy Volunteers

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