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

NCT02075177 · Status: NO_LONGER_AVAILABLE · Type: EXPANDED_ACCESS

Last updated 2022-03-21

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • South Plains Oncology Consortium

    lead NETWORK

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02075177 on ClinicalTrials.gov