Ignite Creation Date:
2024-05-05 @ 10:47 PM
Last Modification Date:
2024-10-26 @ 10:24 AM
Study NCT ID:
NCT01187810
Status:
TERMINATED
Last Update Posted:
2022-03-31
First Post:
2010-08-23
Brief Title:
Fenretinide in Children With RecurrentResistant ALL AML and NHL
Sponsor:
South Plains Oncology Consortium
Organization:
South Plains Oncology Consortium
Study Overview
Official Title:
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-Hodgkins Lymphoma NHL IND 70058
Status:
TERMINATED
Status Verified Date:
2022-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
drug supply
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 andor resistant acute lymphoblastic leukemia ALL acute myelogenous leukemia AML and non-Hodgkins lymphoma NHL
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 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None