Ignite Creation Date:
2025-12-24 @ 5:05 PM
Ignite Modification Date:
2025-12-29 @ 11:11 AM
Study NCT ID:
NCT01019850
Status:
COMPLETED
Last Update Posted:
2023-04-10
First Post:
2009-11-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
N2007-03: Vorinostat and 131-I MIBG in Treating Patients With Resistant or Relapsed Neuroblastoma
Sponsor:
New Approaches to Neuroblastoma Therapy Consortium
Organization:
Study Overview
Official Title:
Vorinostat With 131-I MIBG Therapy for Resistant/Relapsed Neuroblastoma: A Phase I Study IND# 105,744
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: Vorinostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Radioactive drugs, such as iobenguane I 131, may carry radiation directly to tumor cells and not harm normal cells. Giving vorinostat together with iobenguane I 131 may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of giving vorinostat together with iobenguane I 131 in treating patients with resistant or relapsed neuroblastoma.
PURPOSE: This phase I trial is studying the side effects and best dose of giving vorinostat together with iobenguane I 131 in treating patients with resistant or relapsed neuroblastoma.
Detailed Description:
OBJECTIVES:
Primary
* To determine the maximum tolerated dose of vorinostat in combination with iobenguane I 131 in patients with resistant or relapsed neuroblastoma.
* To define the toxicities of vorinostat in combination with therapeutic doses of iobenguane I 131 in these patients.
Secondary
* To describe, within the context of a phase I study, the response rate in patients treated with vorinostat and iobenguane I 131.
* To describe histone acetylation levels and norepinephrine transporter mRNA levels in peripheral blood mononuclear cells after treatment with different doses of vorinostat.
OUTLINE: This is a multicenter study.
Patients receive oral vorinostat once daily on days 1-14 and iobenguane I 131 IV over 1½-2 hours on day 3. Patients undergo autologous peripheral blood stem cell transplantation on day 17.
Blood samples may be collected periodically for correlative biological studies.
After completion of study treatment, patients are followed up periodically.
Primary
* To determine the maximum tolerated dose of vorinostat in combination with iobenguane I 131 in patients with resistant or relapsed neuroblastoma.
* To define the toxicities of vorinostat in combination with therapeutic doses of iobenguane I 131 in these patients.
Secondary
* To describe, within the context of a phase I study, the response rate in patients treated with vorinostat and iobenguane I 131.
* To describe histone acetylation levels and norepinephrine transporter mRNA levels in peripheral blood mononuclear cells after treatment with different doses of vorinostat.
OUTLINE: This is a multicenter study.
Patients receive oral vorinostat once daily on days 1-14 and iobenguane I 131 IV over 1½-2 hours on day 3. Patients undergo autologous peripheral blood stem cell transplantation on day 17.
Blood samples may be collected periodically for correlative biological studies.
After completion of study treatment, patients are followed up periodically.
Study Oversight
Has Oversight DMC:
True
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| P01CA081403 | NIH | None | https://reporter.nih.gov/quic… | View |
| N2007-03 | OTHER | NANT Consortium | View |