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NCT01404702 · ClinicalTrials.gov registry record · Phase 1
Pilot Study of Zoledronic Acid and Interleukin-2 for Refractory Pediatric Neuroblastoma
A Phase 1 study, sponsored by University of Alabama at Birmingham.
- Terminated
- Registry status
- Phase 1
- Development phase
- 4
- Enrollment target
NCT01404702 is a Phase 1 study that was terminated before completion, run by University of Alabama at Birmingham. The registered enrollment target is 4 participants.
The verdict
NCT01404702, a Phase 1 study, was terminated before completion, sponsored by University of Alabama at Birmingham.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 4 participants
- Enrollment target
Study Summary
Neuroblastoma (NB) is the most common extracranial solid tumor in children, with an annual incidence of 10.5 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 and/or 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.
Interventions
- BIOLOGICAL Aldesleukin
- DRUG Zoledronic Acid
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 4 participants |
| Start Date | 2011-08 |
| Est. Completion | 2014-08 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01404702
The ClinicalTrials.gov registry entry for NCT01404702 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 4 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Alabama at Birmingham, which has 1,160 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Aldesleukin is the first listed.
NCT01404702 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01404702 about?
NCT01404702 is a clinical study titled "Pilot Study of Zoledronic Acid and Interleukin-2 for Refractory Pediatric Neuroblastoma". Neuroblastoma (NB) is the most common extracranial solid tumor in children, with an annual incidence of 10.5 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, s...
What is the current status of trial NCT01404702?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 4 participants. The study started on 2011-08. Estimated completion is 2014-08.
What interventions are being tested in trial NCT01404702?
The interventions under investigation include: Aldesleukin (BIOLOGICAL), Zoledronic Acid (DRUG).
Who is sponsoring clinical trial NCT01404702?
This trial is sponsored by University of Alabama at Birmingham, which has 1,160 total clinical trials registered on ClinicalTrials.gov.
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