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NCT02168270 · ClinicalTrials.gov registry record · Phase 1

Temozolomide and Ascorbic Acid in Treating Patients With Recurrent High-Grade Glioma

A Phase 1 study, sponsored by University of Nebraska.

Terminated
Registry status
Phase 1
Development phase
4
Enrollment target

NCT02168270: Clinical Trial Phase 1 study, sponsored by University of Nebraska.

NCT02168270 is a Phase 1 study that was terminated before completion, run by University of Nebraska. 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.

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The verdict

NCT02168270, a Phase 1 study, was terminated before completion, sponsored by University of Nebraska.

TERMINATED
Registry status
Phase 1
Development phase
4 participants
Enrollment target

Study Summary

This phase I trial studies the side effects and best dose of ascorbic acid when given together with temozolomide in treating patients with high-grade glioma that has come back. Drugs used in chemotherapy, such as temozolomide, 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. Ascorbic acid contains ingredients that may prevent or slow the growth of high-grade gliomas. Giving temozolomide with ascorbic acid may kill more tumor cells.

Primary Outcome

Maximum tolerated dose of ascorbic acid in combination with temozolomide, defined as the highest dose tested which results in dose limiting toxicity (DLT) in no more than one of six evaluable patients. Graded by the National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events version 4.0. DLT incidence will be described by dose level.

Interventions

  • OTHER laboratory biomarker analysis
  • DRUG temozolomide
  • OTHER quality-of-life assessment
  • DIETARY_SUPPLEMENT ascorbic acid

Trial Details

FieldValue
Enrollment Target 4 participants
Start Date 2014-06-16
Est. Completion 2015-08-20
Phase Phase 1
University of Nebraska

407 total trials

Why NCT02168270 stopped before completion

NCT02168270 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 4 interventions - of which laboratory biomarker analysis is the first listed.

NCT02168270 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02168270 about?

NCT02168270 is a clinical study titled "Temozolomide and Ascorbic Acid in Treating Patients With Recurrent High-Grade Glioma". This phase I trial studies the side effects and best dose of ascorbic acid when given together with temozolomide in treating patients with high-grade glioma that has come back. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killi...

What is the current status of trial NCT02168270?

This trial is currently terminated. It is a Phase 1 study. The enrollment target is 4 participants. The study started on 2014-06-16. Estimated completion is 2015-08-20.

What interventions are being tested in trial NCT02168270?

The interventions under investigation include: laboratory biomarker analysis (OTHER), temozolomide (DRUG), quality-of-life assessment (OTHER), ascorbic acid (DIETARY_SUPPLEMENT).

Who is sponsoring clinical trial NCT02168270?

This trial is sponsored by University of Nebraska, which has 407 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02168270'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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Source: ClinicalTrials.gov NCT02168270, the US trial registry maintained by the National Library of Medicine. NCT02168270 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.