Ignite Creation Date:
2024-05-05 @ 4:43 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00295919
Status:
COMPLETED
Last Update Posted:
2023-04-07
First Post:
2006-02-23
Brief Title:
N2004-04 Fenretinide LXS in Treating Patients With Recurrent Refractory or Persistent Neuroblastoma
Sponsor:
Childrens Hospital Los Angeles
Organization:
Childrens Hospital Los Angeles
Study Overview
Official Title:
Phase I Study of Fenretinide 4-HPR NSC 374551 Lym-X-Sorb LXS Oral Powder in Patients With Recurrent or Resistant Neuroblastoma
Status:
COMPLETED
Status Verified Date:
2023-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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
Detailed Description:
OBJECTIVES
Primary
Determine the maximum tolerated dose of fenretinide 4-HPR Lym-X-Sorb LXS oral powder 4-HPRLXS oral powder in patients with recurrent refractory or persistent neuroblastoma
Define the toxicities of 4-HPRLXS oral powder in these patients
Determine the plasma pharmacokinetics of 4-HPRLXS oral powder and its metabolites in these patients
Determine the tolerability of the combination of ketoconazole and 4-HPRLXS oral powder in these patients
Secondary
Determine the response rate in patients treated with 4-HPRLXS oral powder
Determine the level of 4-HPRLXS oral powder in normal peripheral blood mononuclear cells PBMC as a tumor cell surrogate tissue
Determine plasma levels of 4-HPRLXS oral powder when given in combination with ketoconazole
Determine whether ketoconazole increases 4-HPRLXS oral powder plasma levels
OUTLINE This is a dose-escalation study of fenretinide 4-HPR Lym-X-Sorb LXS oral powder followed by an open-label study Patients are sequentially assigned to 1 of 2 intervention groups
Group I Patients receive 4-HPRLXS oral powder 3 times daily on days 0-6
Group II Patients receive 4-HPRLXS oral powder as in group I and oral ketoconazole once daily on days 0-6
In both groups treatment repeats every 21 days for at least 6 courses in the absence of disease progression or unacceptable toxicity Patients in complete remission at study enrollment may receive up to 12 courses 9 months of therapy
Blood samples are collected at baseline and during courses 1 2 and 6 for pharmacokinetic and correlative studies
After completion of study treatment patients are followed periodically
PROJECTED ACCRUAL A total of 32 patients will be accrued for the dose-escalation portion and 36 will be accrued for the open-label portion of this study
Primary
Determine the maximum tolerated dose of fenretinide 4-HPR Lym-X-Sorb LXS oral powder 4-HPRLXS oral powder in patients with recurrent refractory or persistent neuroblastoma
Define the toxicities of 4-HPRLXS oral powder in these patients
Determine the plasma pharmacokinetics of 4-HPRLXS oral powder and its metabolites in these patients
Determine the tolerability of the combination of ketoconazole and 4-HPRLXS oral powder in these patients
Secondary
Determine the response rate in patients treated with 4-HPRLXS oral powder
Determine the level of 4-HPRLXS oral powder in normal peripheral blood mononuclear cells PBMC as a tumor cell surrogate tissue
Determine plasma levels of 4-HPRLXS oral powder when given in combination with ketoconazole
Determine whether ketoconazole increases 4-HPRLXS oral powder plasma levels
OUTLINE This is a dose-escalation study of fenretinide 4-HPR Lym-X-Sorb LXS oral powder followed by an open-label study Patients are sequentially assigned to 1 of 2 intervention groups
Group I Patients receive 4-HPRLXS oral powder 3 times daily on days 0-6
Group II Patients receive 4-HPRLXS oral powder as in group I and oral ketoconazole once daily on days 0-6
In both groups treatment repeats every 21 days for at least 6 courses in the absence of disease progression or unacceptable toxicity Patients in complete remission at study enrollment may receive up to 12 courses 9 months of therapy
Blood samples are collected at baseline and during courses 1 2 and 6 for pharmacokinetic and correlative studies
After completion of study treatment patients are followed periodically
PROJECTED ACCRUAL A total of 32 patients will be accrued for the dose-escalation portion and 36 will be accrued for the open-label portion of this study
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| P01CA081403 | NIH | None | None |
| N2004-04 | OTHER | NANT Consortium | httpsreporternihgovquickSearchP01CA081403 |