Clinical trial · Interventional
Fenretinide in Children With Recurrent/Resistant ALL, AML, and NHL
A Phase I Study of Intravenous (Emulsion) Fenretinide (4-HPR, NSC 374551) in Children With Recurrent or Resistant Acute Lymphoblastic Leukemia (ALL), Acute Myelogenous Leukemia (AML), and Non-Hodgkin's Lymphoma (NHL) IND #70,058"
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): drug supply
Summary
Brief summary (as posted)
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).
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Lymphoblastic Leukemia | Acute Lymphoblastic Leukemia | ONTOLOGY_EXACT | 0.98 |
| Acute Myelogenous Leukemia | Acute Myeloid Leukemia | ALIAS | 0.90 |
| Non-Hodgkin's Lymphoma | Non-Hodgkin Lymphoma | ALIAS | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cytarabine | Drug | Cytarabine | ALIAS |
| Fenretinide | Drug | — | UNRESOLVED |
| Methotrexate | Drug | Methotrexate | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Combination of Fenretinide, Cytarabine, and Methotrexate
- description
- IV for 7 days for each 21 day cycle
- interventionNames
- Drug: Fenretinide
- Drug: Cytarabine
- Drug: Methotrexate
Primary outcomes (3)
- measure
- Determine maximum tolerated dose
- timeFrame
- end of study
- measure
- Define systemic toxicities
- timeFrame
- end of study
- measure
- Determine plasma pharmacokinetics
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 21 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available