NCT02075177

Expanded Access Study of Fenretinide Lym-X-Sorb Plus Ketoconazole in Neuroblastoma

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)

• Status: No Longer Available
• Phase: —
• Study type: Expanded Access
• Enrollment: —
• Sponsor: South Plains Oncology Consortium · Network
• Sex: All
• Age: —
• Healthy volunteers: —

Summary

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.

Conditions

• Recurrent Neuroblastoma
• Neuroblastoma

Interventions

Type	Name	Description
DRUG	Fenretinide Lym-X-Sorb Oral Powder	Fenretinide Lym-X-Sorb 1500 mg/m2/day, daily for 7 days every 3 weeks
DRUG	Ketoconazole	Ketoconazole 6 mg/kg/day, daily for 7 days every 3 weeks.

Timeline

• First posted: 2014-03-03
• Last updated: 2022-03-21

Locations

3 sites across 1 country: United States