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Phase I Study of Fenretinide (4-HPR, NSC 374551) Lym-X-Sorb™ (LXS) Oral Powder in Patients With Recurrent or Resistant Neuroblastoma
RATIONALE: Drugs used in chemotherapy, such as fenretinide LXS, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. PURPOSE: This phase I trial is studying the side effects and best dose of fenretinide LXS in treating patients with recurrent, refractory, or persistent neuroblastoma.
Details
| Lead sponsor | New Approaches to Neuroblastoma Therapy Consortium |
|---|---|
| Phase | Phase 1 |
| Status | COMPLETED |
| Enrolment | 80 |
| Start date | 2005-12 |
| Completion | 2015-05 |
Conditions
- Neuroblastoma
Interventions
- fenretinide lipid matrix
- ketoconazole
- laboratory biomarker analysis
- pharmacological study
Primary outcomes
- Maximum tolerated dose — Day 1 of therapy to 16 days after last day of therapy
- Toxicity of HPR/LXS oral powder — Day 1 of therapy to 16 days after last day of therapy
- Plasma pharmacokinetics of 4-HPR/LXS oral powder and its metabolites — Day 0 of protocol therapy through Day 6 of Course 6
- Tolerability of the combination of ketoconazole and 4-HPR/LXS oral powder — Day 1 of therapy to 16 days after last day of therapy
Countries
United States