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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: Clinical Trial Phase 1 study, sponsored by University of Alabama at Birmingham.
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, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (93% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The NCI Common Terminology Criteria for AEs will be used for reporting \& identification of dose limiting toxicities. DLTs will include any grade 3 non-hematologic toxicity not included here: Gr 3 nausea \& vomiting \& diarrhea, Gr 3 fever, Gr 3 skin toxicity that remains stable \& tolerable, or improves with treatment within 24 hrs, Gr 3 neurotoxicity with subjective findings, Gr 4 hematologic toxicity, which improves to at least Gr 2 or baseline pre-therapy values within one week of completing
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 |
Why NCT01404702 stopped before completion
NCT01404702 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 4 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (93% lower).
The record links to 0 conditions, and to 2 interventions - of which Aldesleukin is the first listed.
NCT01404702 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01404702's enrollment target sits among peer trials
4 1995th of 2000 higher than 2 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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