Ignite Creation Date:
2024-05-05 @ 11:45 PM
Last Modification Date:
2024-10-26 @ 10:38 AM
Study NCT ID:
NCT01404702
Status:
TERMINATED
Last Update Posted:
2014-12-02
First Post:
2011-07-13
Brief Title:
Pilot Study of Zoledronic Acid and Interleukin-2 for Refractory Pediatric Neuroblastoma
Sponsor:
University of Alabama at Birmingham
Organization:
University of Alabama at Birmingham
Study Overview
Official Title:
Pilot Study of Zoledronic Acid and Interleukin-2 for Refractory Pediatric Neuroblastoma Assessment of Tolerability and In Vivo Expansion γδ T-Cells
Status:
TERMINATED
Status Verified Date:
2014-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Accrual slower than anticipated
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Neuroblastoma NB is the most common extracranial solid tumor in children with an annual incidence of 105 per million children less than 15 years of age NB accounts for 15 of childhood cancer deaths High risk HR patients carry a poor prognosis despite treatment with intensive chemotherapy surgery andor radiation autologous bone marrow transplant and treatment with cis-retinoic acid New therapies are desperately needed for such patients Recently it has been demonstrated that HR NB patients benefit from anti-GD2 antibody therapy which directs the immune system against NB cells To further explore means of harnessing the immune system to attack NB the investigators are studying the combination of zoledronic acid ZOL and interleukin-2 IL-2 ZOL has been demonstrated to have direct anti-neuroblastoma effects in laboratory studies ZOL also augments the production of tumor killing white blood cells called gamma-delta T cells When used in combination with IL-2 ZOL is capable of eliciting potent anti-cancer effects in patients in part via the expansion of gamma-delta T cells In this present trial the investigators aim to study the tolerability of the combination of ZOL and IL-2 in pediatric NB patients Patients will also be monitored radiologically for tumor response to therapy Correlative biological studies will study the ability of this drug combination to elicit the production of NB killing gamma-delta T cells in children
Detailed Description:
None
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 |
|---|---|---|---|
| F101013003 | OTHER | UAB Institutional Board for Human Use | None |