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NCT01076530 · ClinicalTrials.gov registry record · Phase 1

Vorinostat and Temozolomide in Treating Young Patients With Relapsed or Refractory Primary Brain Tumors or Spinal Cord Tumors

A Phase 1 study, sponsored by National Cancer Institute (NCI).

Completed
Registry status
Phase 1
Development phase
27
Enrollment target

NCT01076530: Completed Phase 1 study, sponsored by National Cancer Institute (NCI).

NCT01076530 is a Phase 1 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 27 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (55% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01076530, a Phase 1 study, has completed, sponsored by National Cancer Institute (NCI).

COMPLETED
Registry status
Phase 1
Development phase
27 participants
Enrollment target

Study Summary

This phase I trial is studying the side effects and best dose of vorinostat when given together with temozolomide in treating young patients with relapsed or refractory primary brain tumors or spinal cord tumors. 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. Vorinostat may help temozolomide work better by making tumor cells more sensitive to the drug.

Primary Outcome

In addition to determination of the MTD, a descriptive summary of all toxicities will be reported.

Interventions

  • DRUG vorinostat
  • DRUG temozolomide
  • OTHER pharmacological study
  • OTHER diagnostic laboratory biomarker analysis

Trial Details

FieldValue
Enrollment Target 27 participants
Start Date 2010-02
Phase Phase 1
National Cancer Institute (NCI)

3,257 total trials

What the finished NCT01076530 record still lists

NCT01076530 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 27 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (55% lower).

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

NCT01076530 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01076530 about?

NCT01076530 is a clinical study titled "Vorinostat and Temozolomide in Treating Young Patients With Relapsed or Refractory Primary Brain Tumors or Spinal Cord Tumors". This phase I trial is studying the side effects and best dose of vorinostat when given together with temozolomide in treating young patients with relapsed or refractory primary brain tumors or spinal cord tumors. Vorinostat may stop the growth of tumor cells by blocking some of the enzymes needed fo...

What is the current status of trial NCT01076530?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 27 participants. The study started on 2010-02.

What interventions are being tested in trial NCT01076530?

The interventions under investigation include: vorinostat (DRUG), temozolomide (DRUG), pharmacological study (OTHER), diagnostic laboratory biomarker analysis (OTHER).

Who is sponsoring clinical trial NCT01076530?

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 NCT01076530's enrollment target sits among peer trials

27 1463rd of 2000 higher than 519 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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Source: ClinicalTrials.gov NCT01076530, the US trial registry maintained by the National Library of Medicine. NCT01076530 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.