Ignite Creation Date:
2024-05-06 @ 2:56 AM
Last Modification Date:
2024-10-26 @ 11:25 AM
Study NCT ID:
NCT02163356
Status:
TERMINATED
Last Update Posted:
2022-03-31
First Post:
2014-05-27
Brief Title:
Fenretinide Lym-X-Sorb Ketoconazole Vincristine for Recurrent or Resistant Neuroblastoma
Sponsor:
South Plains Oncology Consortium
Organization:
South Plains Oncology Consortium
Study Overview
Official Title:
Phase I Study of Fenretinide 4-HPR NSC 374551 Lym-X-Sorb LXS Oral Powder Plus Ketoconazole Plus Vincristine in Patients With Recurrent or Resistant Neuroblastoma IND 68254
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:
SPOC2013-001
Brief Summary:
Currently there is no known effective treatment for recurrent or resistant neuroblastoma Fenretinide is an anticancer agent that may work differently than standard chemotherapy It may cause the buildup of wax-like substances in cancer cells called ceramides In laboratory studies it was found that if too much ceramide builds up in the neuroblastoma cells they die
Fenretinide has been given by mouth as a capsule to many people including children When Fenretinide is given in capsules very little of the drug is absorbed through the intestines into the body This means patients have to take many capsules of fenretinide by mouth several times a day In this study a new oral preparation of fenretinide called 4-HPRLXS oral powder is being tested to see if more fenretinide can be absorbed into the body 4-HPRLXS oral powder has been tested previously in a limited number of both children and adult cancer patients
Ketoconazole commonly used to treat fungus infections can increase fenretinide levels in the body by interfering with the bodys ability to break down fenretinide Ketoconazole will be given at the same time as the fenretinide powder
There is preclinical data that shows that combining fenretinide and vincristine prolonged survival in animal models therefore it is hoped that giving the vincristine with fenretinide will work better against the neuroblastoma that either drug given alone
About 70 children with neuroblastoma have been treated with various versions of the fenretinide powder to date including about a dozen children that also took the fenretinide powder with ketoconazole and no toxicities have occurred that limited the dosage and no serious or unexpected side effects occurred However vincristine has never been given with fenretinide or fenretinide plus ketoconazole before Vincristine has been been given before with ketoconazole to both children and adults with neuroblastomas and other cancers
Fenretinide has been given by mouth as a capsule to many people including children When Fenretinide is given in capsules very little of the drug is absorbed through the intestines into the body This means patients have to take many capsules of fenretinide by mouth several times a day In this study a new oral preparation of fenretinide called 4-HPRLXS oral powder is being tested to see if more fenretinide can be absorbed into the body 4-HPRLXS oral powder has been tested previously in a limited number of both children and adult cancer patients
Ketoconazole commonly used to treat fungus infections can increase fenretinide levels in the body by interfering with the bodys ability to break down fenretinide Ketoconazole will be given at the same time as the fenretinide powder
There is preclinical data that shows that combining fenretinide and vincristine prolonged survival in animal models therefore it is hoped that giving the vincristine with fenretinide will work better against the neuroblastoma that either drug given alone
About 70 children with neuroblastoma have been treated with various versions of the fenretinide powder to date including about a dozen children that also took the fenretinide powder with ketoconazole and no toxicities have occurred that limited the dosage and no serious or unexpected side effects occurred However vincristine has never been given with fenretinide or fenretinide plus ketoconazole before Vincristine has been been given before with ketoconazole to both children and adults with neuroblastomas and other cancers
Detailed Description:
Fenretinide has been given by mouth as a capsule to many people including children When Fenretinide is given in capsules very little of the drug is absorbed through the intestines into the body This means patients have to take many capsules of fenretinide by mouth several times a day In this study a new oral preparation of fenretinide called 4-HPRLXS oral powder is being tested to see if more fenretinide can be absorbed into the body 4-HPRLXS oral powder has been tested previously in a limited number of both children and adult cancer patients
Ketoconazole commonly used to treat fungus infections can increase fenretinide levels in the body by interfering with the bodys ability to break down fenretinide Ketoconazole will be given at the same time as the fenretinide powder
There is preclinical data that shows that combining fenretinide and vincristine prolonged survival in animal models therefore it is hoped that giving the vincristine with fenretinide will work better against the neuroblastoma that either drug given alone
About 70 children with neuroblastoma have been treated with various versions of the fenretinide powder to date including about a dozen children that also took the fenretinide powder with ketoconazole and no toxicities have occurred that limited the dosage and no serious or unexpected side effects occurred However vincristine has never been given with fenretinide or fenretinide plus ketoconazole before Vincristine has been been given before with ketoconazole to both children and adults with neuroblastomas and other cancers
Ketoconazole commonly used to treat fungus infections can increase fenretinide levels in the body by interfering with the bodys ability to break down fenretinide Ketoconazole will be given at the same time as the fenretinide powder
There is preclinical data that shows that combining fenretinide and vincristine prolonged survival in animal models therefore it is hoped that giving the vincristine with fenretinide will work better against the neuroblastoma that either drug given alone
About 70 children with neuroblastoma have been treated with various versions of the fenretinide powder to date including about a dozen children that also took the fenretinide powder with ketoconazole and no toxicities have occurred that limited the dosage and no serious or unexpected side effects occurred However vincristine has never been given with fenretinide or fenretinide plus ketoconazole before Vincristine has been been given before with ketoconazole to both children and adults with neuroblastomas and other cancers
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