Expanded Access Study of Fenretinide Lym-X-Sorb Plus Ketoconazole in Neuroblastoma
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02075177|
Expanded Access Status : Available
First Posted : March 3, 2014
Last Update Posted : May 24, 2017
Currently there is no known effective treatment for recurrent/resistant 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 body's ability to break down fenretinide.
This study is being done: 1) to allow patients with recurrent/refractory neuroblastoma patients who would otherwise not be able to access fenretinide/LXS 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 patient's tumor gets smaller after treatment with fenretinide oral powder plus ketoconazole or fenretinide oral powder alone.
|Condition or disease||Intervention/treatment|
|Recurrent Neuroblastoma Neuroblastoma||Drug: Fenretinide Lym-X-Sorb Oral Powder Drug: Ketoconazole|
|Study Type :||Expanded Access|
|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 (IND#68,254)|
- Drug: Fenretinide Lym-X-Sorb Oral Powder
Fenretinide Lym-X-Sorb 1500 mg/m2/day, daily for 7 days every 3 weeksOther Names:
- Drug: Ketoconazole
Ketoconazole 6 mg/kg/day, daily for 7 days every 3 weeks.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02075177
|Contact: Amanda Knight, RN, BSNfirstname.lastname@example.org|
|United States, Oklahoma|
|University of Oklahoma Health Science Center|
|Oklahoma City, Oklahoma, United States, 79104|
|Contact: William Meyer, MD 405-271-4000 Williamemail@example.com|
|Principal Investigator: William Meyer, MD|
|United States, Texas|
|UT Southwestern Medical Center|
|Dallas, Texas, United States, 75235|
|Contact: Tanya Watt, MD 214-456-6363 tanya.watt@UTSouthwestern.edu|
|Principal Investigator: Tanya Watt, MD|
|Cook Children's Hospital|
|Fort Worth, Texas, United States, 76104|
|Contact: Meaghan Granger, MD 817-336-4896 meaghan.grangerMD@cookschildrens.org|
|Principal Investigator: Meaghan Granger, MD|