Ignite Creation Date:
2024-05-05 @ 10:22 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003191
Status:
COMPLETED
Last Update Posted:
2013-02-07
First Post:
1999-11-01
Brief Title:
Fenretinide in Treating Children With Solid Tumors
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase I Study of Fenretinide NSC 374551 in Children With High Risk Solid Tumors
Status:
COMPLETED
Status Verified Date:
2006-08
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:
Phase I trial to study the effectiveness of fenretinide in treating children who have solid tumors that have not responded to standard therapy Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die
Detailed Description:
OBJECTIVES
I Determine the maximum tolerated dose of fenretinide HPR in children with high risk solid tumors
II Determine the toxicities of HPR in these patients III Determine the pharmacokinetics of HPR in these patients IV Determine the CSF level of HPR in patients whom cerebrospinal fluid is obtained for routine purposes while on this study
V Determine the effect of HPR on plasma retinol levels in these patients VI Determine the activity of HPR in these patients VII Determine the antitumor activity of HPR on minimal residual bone marrow disease in neuroblastoma
OUTLINE This is a dose escalation study
Patients receive oral fenretinide 3 times a day on days 1-7 Treatment repeats every 3 weeks for up to 8 courses Patients may receive an additional 22 courses of therapy in the presence of stable or responding residual tumor Patients with recurrent neuroblastoma after prior myeloablative therapy with no measurable disease will stop treatment after 8 courses Cohorts of 3-6 patients receive escalating doses of fenretinide until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose limiting toxicity
Patients are followed until death
I Determine the maximum tolerated dose of fenretinide HPR in children with high risk solid tumors
II Determine the toxicities of HPR in these patients III Determine the pharmacokinetics of HPR in these patients IV Determine the CSF level of HPR in patients whom cerebrospinal fluid is obtained for routine purposes while on this study
V Determine the effect of HPR on plasma retinol levels in these patients VI Determine the activity of HPR in these patients VII Determine the antitumor activity of HPR on minimal residual bone marrow disease in neuroblastoma
OUTLINE This is a dose escalation study
Patients receive oral fenretinide 3 times a day on days 1-7 Treatment repeats every 3 weeks for up to 8 courses Patients may receive an additional 22 courses of therapy in the presence of stable or responding residual tumor Patients with recurrent neuroblastoma after prior myeloablative therapy with no measurable disease will stop treatment after 8 courses Cohorts of 3-6 patients receive escalating doses of fenretinide until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose limiting toxicity
Patients are followed until death
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 |
|---|---|---|---|
| CDR0000066023 | REGISTRY | PDQ Physician Data Query | None |
| CCG-09709 | None | None | None |