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NCT01217437 · ClinicalTrials.gov registry record · Phase 2

Temozolomide and Irinotecan Hydrochloride With or Without Bevacizumab in Treating Young Patients With Recurrent or Refractory Medulloblastoma or CNS Primitive Neuroectodermal Tumors

A Phase 2 study, sponsored by National Cancer Institute (NCI).

Completed
Registry status
Phase 2
Development phase
108
Enrollment target

NCT01217437: Completed Phase 2 study, sponsored by National Cancer Institute (NCI).

NCT01217437 is a Phase 2 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 108 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (19% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01217437, a Phase 2 study, has completed, sponsored by National Cancer Institute (NCI).

COMPLETED
Registry status
Phase 2
Development phase
108 participants
Enrollment target

Study Summary

This randomized phase II trial studies how well giving temozolomide and irinotecan hydrochloride together with or without bevacizumab works in treating young patients with recurrent or refractory medulloblastoma or central nervous system (CNS) primitive neuroectodermal tumors. Drugs used in chemotherapy, such as temozolomide and irinotecan hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. It is not yet known whether temozolomide and irinotecan hydrochloride are more effective with or without bevacizumab in treating medulloblastoma or CNS primitive neuroectodermal tumors.

Primary Outcome

Percentage Probability of remaining alive 5 years after enrollment estimated by the method of Kaplan and Meier

Interventions

  • DRUG Temozolomide
  • BIOLOGICAL Bevacizumab
  • DRUG Irinotecan Hydrochloride

Trial Details

FieldValue
Enrollment Target 108 participants
Start Date 2010-11-22
Est. Completion 2021-06-30
Phase Phase 2
National Cancer Institute (NCI)

3,257 total trials

What the finished NCT01217437 record still lists

NCT01217437 is an interventional study that assigns participants to a tested intervention. The registered 108 participants enrollment target is mid-sized for trials with a published cap, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (19% lower).

The record links to 0 conditions, and to 3 interventions - of which Temozolomide is the first listed.

NCT01217437 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01217437 about?

NCT01217437 is a clinical study titled "Temozolomide and Irinotecan Hydrochloride With or Without Bevacizumab in Treating Young Patients With Recurrent or Refractory Medulloblastoma or CNS Primitive Neuroectodermal Tumors". This randomized phase II trial studies how well giving temozolomide and irinotecan hydrochloride together with or without bevacizumab works in treating young patients with recurrent or refractory medulloblastoma or central nervous system (CNS) primitive neuroectodermal tumors. Drugs used in chemothe...

What is the current status of trial NCT01217437?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 108 participants. The study started on 2010-11-22. Estimated completion is 2021-06-30.

What interventions are being tested in trial NCT01217437?

The interventions under investigation include: Temozolomide (DRUG), Bevacizumab (BIOLOGICAL), Irinotecan Hydrochloride (DRUG).

Who is sponsoring clinical trial NCT01217437?

This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01217437's enrollment target sits among peer trials

108 640th of 2000 higher than 1,355 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 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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Source: ClinicalTrials.gov NCT01217437, the US trial registry maintained by the National Library of Medicine. NCT01217437 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.