Ignite Creation Date:
2024-05-05 @ 11:29 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00053326
Status:
COMPLETED
Last Update Posted:
2013-10-08
First Post:
2003-01-27
Brief Title:
Fenretinide in Treating Children With Recurrent or Resistant Neuroblastoma
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase II Study of Fenretinide NSC 374551 IND 40294 in Children With RecurrentResistant High Risk Neuroblastoma
Status:
COMPLETED
Status Verified Date:
2013-10
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:
This phase II trial is studying how well fenretinide works in treating children with recurrent or resistant neuroblastoma Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die
Detailed Description:
OBJECTIVES
Determine the response rate in pediatric patients with recurrent or resistant high-risk neuroblastoma treated with fenretinide
Determine the toxic effects of this drug in these patients Determine the proportion of patients with disease detected only by bone marrow immunocytology who clear all evidence of disease during treatment with this drug
Determine minimal residual disease response by marrow and meta-iodobenzylguanidine MIBG I 123 scan in patients treated with this drug
OUTLINE Patients are stratified according to presence of measurable disease on CT scanMRI yes vs no A third stratum of patients with tumor cells in bone marrow by immunocytology only is enrolled but is not evaluated for response
Patients receive oral fenretinide 3 times daily or 2 times daily if over 18 years of age on days 1-7 Treatment repeats every 3 weeks for up to 30 courses in the absence of disease progression or unacceptable toxicity Patients in stratum III who fail to achieve a complete response after 8 courses of therapy are removed from study
Patients are followed monthly until blood counts and visual acuity are stable or normalized and then every 6 months for 2 years and annually for 3 years
PROJECTED ACCRUAL A total of 70 patients 25 each for strata I and II 20 for stratum III will be accrued for this study within 1-2 years
Determine the response rate in pediatric patients with recurrent or resistant high-risk neuroblastoma treated with fenretinide
Determine the toxic effects of this drug in these patients Determine the proportion of patients with disease detected only by bone marrow immunocytology who clear all evidence of disease during treatment with this drug
Determine minimal residual disease response by marrow and meta-iodobenzylguanidine MIBG I 123 scan in patients treated with this drug
OUTLINE Patients are stratified according to presence of measurable disease on CT scanMRI yes vs no A third stratum of patients with tumor cells in bone marrow by immunocytology only is enrolled but is not evaluated for response
Patients receive oral fenretinide 3 times daily or 2 times daily if over 18 years of age on days 1-7 Treatment repeats every 3 weeks for up to 30 courses in the absence of disease progression or unacceptable toxicity Patients in stratum III who fail to achieve a complete response after 8 courses of therapy are removed from study
Patients are followed monthly until blood counts and visual acuity are stable or normalized and then every 6 months for 2 years and annually for 3 years
PROJECTED ACCRUAL A total of 70 patients 25 each for strata I and II 20 for stratum III will be accrued for this study within 1-2 years
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 |
|---|---|---|---|
| NCI-2012-01802 | REGISTRY | None | None |
| COG-ADVL0024 | None | None | None |
| COG-A0996 | None | None | None |
| CDR0000269408 | None | None | None |
| COG-ANBL0321 | None | None | None |
| ADVL0024 | OTHER | None | None |
| ANBL0321 | OTHER | None | None |
| U10CA098543 | NIH | CTEP | httpsreporternihgovquickSearchU10CA098543 |