Ignite Creation Date:
2024-05-06 @ 2:34 AM
Last Modification Date:
2024-10-26 @ 11:20 AM
Study NCT ID:
NCT02075177
Status:
NO_LONGER_AVAILABLE
Last Update Posted:
2022-03-21
First Post:
2014-02-27
Brief Title:
Expanded Access Study of Fenretinide Lym-X-Sorb Plus Ketoconazole in Neuroblastoma
Sponsor:
South Plains Oncology Consortium
Organization:
South Plains Oncology Consortium
Study Overview
Official Title:
Expanded Access Study of Fenretinide 4-HPR NSC 374551 Lym-X-Sorb LXS Oral Powder Plus Ketoconazole in Patients With Recurrent or Resistant Neuroblastoma IND68254
Status:
NO_LONGER_AVAILABLE
Status Verified Date:
2022-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Currently there is no known effective treatment for recurrentresistant neuroblastoma
Fenretinide is an anticancer agent that may work differently than standard chemotherapy medicines It may cause the buildup of wax-like substances in neuroblastoma cancer cells called ceramides or other chemicals called reactive oxygen species In laboratory studies it was found that if too much ceramide or reactive oxygen species build up in neuroblastoma cells they may die
In addition researchers are testing to see if a drug called ketoconazole commonly used to treat fungus infections can increase fenretinide levels in the body by interfering with the bodys ability to break down fenretinide
This study is being done 1 to allow patients with recurrentrefractory neuroblastoma patients who would otherwise not be able to access fenretinideLXS oral powder for treatment to do so 2 to further describe the side effects of fenretinide and ketoconazole when given by mouth for seven days every three weeks 3 to determine if a patients tumor gets smaller after treatment with fenretinide oral powder plus ketoconazole or fenretinide oral powder alone
Fenretinide is an anticancer agent that may work differently than standard chemotherapy medicines It may cause the buildup of wax-like substances in neuroblastoma cancer cells called ceramides or other chemicals called reactive oxygen species In laboratory studies it was found that if too much ceramide or reactive oxygen species build up in neuroblastoma cells they may die
In addition researchers are testing to see if a drug called ketoconazole commonly used to treat fungus infections can increase fenretinide levels in the body by interfering with the bodys ability to break down fenretinide
This study is being done 1 to allow patients with recurrentrefractory neuroblastoma patients who would otherwise not be able to access fenretinideLXS oral powder for treatment to do so 2 to further describe the side effects of fenretinide and ketoconazole when given by mouth for seven days every three weeks 3 to determine if a patients tumor gets smaller after treatment with fenretinide oral powder plus ketoconazole or fenretinide oral powder alone
Detailed Description:
None
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