Ignite Creation Date:
2024-05-05 @ 10:17 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001509
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
1999-11-03
Brief Title:
A Phase II Trial of All-Trans-Retinoic Acid in Combination With Interferon-Alpha 2a in Children With Recurrent Neuroblastoma or Wilms Tumor
Sponsor:
National Cancer Institute NCI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
A Phase II Trial of All-Trans-Retinoic Acid in Combination With Interferon-Alpha 2a in Children With Recurrent Neuroblastoma or Wilms Tumor
Status:
COMPLETED
Status Verified Date:
1999-06
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:
A body of preclinical data has provided a strong rationale for evaluating the combination of IFN-alpha with retinoic acid The two drugs have different mechanisms of action and when used in combination show enhanced activity in both adult and pediatric tumor cell lines
The combination of the antiproliferative and differentiation inducing effect of retinoids together with the antiproliferative immunostimulatory and differentiation-potentiating effects of IFN-alpha warrant clinical investigation of this combination for the treatment of refractory pediatric malignancies
The combination of the antiproliferative and differentiation inducing effect of retinoids together with the antiproliferative immunostimulatory and differentiation-potentiating effects of IFN-alpha warrant clinical investigation of this combination for the treatment of refractory pediatric malignancies
Detailed Description:
A body of preclinical data has provided a strong rationale for evaluating the combination of IFN-alpha with retinoic acid The two drugs have different mechanisms of action and when used in combination show enhanced activity in both adult and pediatric tumor cell lines In the pediatric phase I trial which administered ATRA for 3 consecutive daysweek repeated weekly the AUC of ATRA decreased on day 1 to day 3 of drug administration but returned to day 1 levels at the beginning of subsequent weeks This intermittent schedule of ATRA administration allowed for exposure to relatively high plasma concentrations of ATRA on a repetitive basis The combination of ATRAIFN-alpha 2a has demonstrated clinical activity in the pediatric phase I trial in neuroblastoma and Wilms tumor The combination of the antiproliferative and differentiation inducing effect of retinoids together with the antiproliferative immunostimulatory and differentiation-potentiating effects of IFN-alpha warrant clinical investigation of this combination for the treatment of refractory pediatric malignancies
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 |
|---|---|---|---|
| 96-C-0117 | None | None | None |