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NCT01334515 · ClinicalTrials.gov registry record · Phase 2

Biological Therapy, Sargramostim, and Isotretinoin in Treating Patients With Relapsed or Refractory Neuroblastoma

A Phase 2 study, sponsored by Children's Oncology Group.

Completed
Registry status
Phase 2
Development phase
52
Enrollment target

NCT01334515 is a Phase 2 study that has completed, run by Children's Oncology Group. The registered enrollment target is 52 participants.

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The verdict

NCT01334515, a Phase 2 study, has completed, sponsored by Children's Oncology Group.

COMPLETED
Registry status
Phase 2
Development phase
52 participants
Enrollment target

Study Summary

This phase II trial is studying how well hu14.18-interleukin-2 (IL2) fusion protein works when given together with sargramostim and isotretinoin in treating patients with relapsed or refractory neuroblastoma. Biological therapy, such as hu14.18-IL2 fusion protein, and sargramostim work in different ways to stimulate the immune system and stop tumor cells from growing. Drugs used in chemotherapy, such as isotretinoin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving hu14.18-IL2 fusion protein together with sargramostim and isotretinoin may kill more tumor cells.

Interventions

  • OTHER laboratory biomarker analysis
  • BIOLOGICAL sargramostim
  • DRUG isotretinoin
  • BIOLOGICAL hu14.18-IL2 fusion protein

Trial Details

FieldValue
Enrollment Target 52 participants
Start Date 2011-09
Est. Completion 2019-09-30
Phase Phase 2

Sponsor

Children's Oncology Group

342 total trials

What the Registry Record Tells You About NCT01334515

The ClinicalTrials.gov registry entry for NCT01334515 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 52 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Children's Oncology Group, which has 342 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 4 interventions - of which laboratory biomarker analysis is the first listed.

NCT01334515 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT01334515 about?

NCT01334515 is a clinical study titled "Biological Therapy, Sargramostim, and Isotretinoin in Treating Patients With Relapsed or Refractory Neuroblastoma". This phase II trial is studying how well hu14.18-interleukin-2 (IL2) fusion protein works when given together with sargramostim and isotretinoin in treating patients with relapsed or refractory neuroblastoma. Biological therapy, such as hu14.18-IL2 fusion protein, and sargramostim work in different ...

What is the current status of trial NCT01334515?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 52 participants. The study started on 2011-09. Estimated completion is 2019-09-30.

What interventions are being tested in trial NCT01334515?

The interventions under investigation include: laboratory biomarker analysis (OTHER), sargramostim (BIOLOGICAL), isotretinoin (DRUG), hu14.18-IL2 fusion protein (BIOLOGICAL).

Who is sponsoring clinical trial NCT01334515?

This trial is sponsored by Children's Oncology Group, which has 342 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.