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NCT01236560 · ClinicalTrials.gov registry record · Phase 2

Vorinostat, Temozolomide, or Bevacizumab in Combination With Radiation Therapy Followed by Bevacizumab and Temozolomide in Young Patients With Newly Diagnosed High-Grade Glioma

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

Completed
Registry status
Phase 2
Development phase
101
Enrollment target

NCT01236560: Completed Phase 2 study, sponsored by National Cancer Institute (NCI).

NCT01236560 is a Phase 2 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 101 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (24% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01236560, a Phase 2 study, has completed, sponsored by National Cancer Institute (NCI).

COMPLETED
Registry status
Phase 2
Development phase
101 participants
Enrollment target

Study Summary

This randomized phase II/III trial is studying vorinostat, temozolomide, or bevacizumab to see how well they work compared with each other when given together with radiation therapy followed by bevacizumab and temozolomide in treating young patients with newly diagnosed high-grade glioma. Vorinostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. 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. Radiation therapy uses high-energy x-rays to kill tumor cells. It is not yet known whether giving vorinostat is more effective then temozolomide or bevacizumab when given together with radiation therapy in treating glioma.

Primary Outcome

The dose of vorinostat in mg/sq m/day to be administered with combination chemotherapy and radiation therapy.

Interventions

  • DRUG Temozolomide
  • BIOLOGICAL Bevacizumab
  • DRUG Vorinostat

Trial Details

FieldValue
Enrollment Target 101 participants
Start Date 2011-01-26
Est. Completion 2023-12-31
Phase Phase 2
National Cancer Institute (NCI)

3,257 total trials

What the finished NCT01236560 record still lists

NCT01236560 is an interventional study that assigns participants to a tested intervention. The registered 101 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 (24% lower).

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

NCT01236560 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01236560 about?

NCT01236560 is a clinical study titled "Vorinostat, Temozolomide, or Bevacizumab in Combination With Radiation Therapy Followed by Bevacizumab and Temozolomide in Young Patients With Newly Diagnosed High-Grade Glioma". This randomized phase II/III trial is studying vorinostat, temozolomide, or bevacizumab to see how well they work compared with each other when given together with radiation therapy followed by bevacizumab and temozolomide in treating young patients with newly diagnosed high-grade glioma. Vorinostat...

What is the current status of trial NCT01236560?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 101 participants. The study started on 2011-01-26. Estimated completion is 2023-12-31.

What interventions are being tested in trial NCT01236560?

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

Who is sponsoring clinical trial NCT01236560?

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 NCT01236560's enrollment target sits among peer trials

101 672nd of 2000 higher than 1,329 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 NCT01236560, the US trial registry maintained by the National Library of Medicine. NCT01236560 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.