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NCT01111097 · ClinicalTrials.gov registry record · Phase 1

Study of the Safety and Efficacy of Dichloroacetate (DCA) in Glioblastoma and Other Recurrent Brain Tumors

A Phase 1 study of Glioblastoma and Brain Tumor, sponsored by University of Florida.

Completed
Registry status
Phase 1
Development phase
15
Enrollment target
1
Study location

NCT01111097: Completed Phase 1 study of Glioblastoma and Brain Tumor, sponsored by University of Florida.

NCT01111097 is a Phase 1 study of Glioblastoma and Brain Tumor that has completed, run by University of Florida. The registered enrollment target is 15 participants, below the 109-participant average among 199 other Glioblastoma trials with a reported enrollment target (86% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01111097, a Phase 1 study of Glioblastoma and Brain Tumor, has completed, sponsored by University of Florida.

COMPLETED
Registry status
Phase 1
Development phase
15 participants
Enrollment target
1
Study location

Study Summary

The purpose of this study is to evaluate the safety and tolerability of oral Dichloroacetate (DCA) in the treatment of recurrent malignant brain tumors (RMBTs). RMBTs are defined as either: 1) malignant tumors, originating in the brain, that have recurred at least once or 2) malignant tumors originating elsewhere in the body that have spread to the brain at least once. Otherwise, there are no limitations to the number of prior recurrences. There are no limitations to the number or types of prior therapies.

Primary Outcome

Oral DCA will be administered until intolerance, toxicity, radiographic progression, or death. Safety and tolerance will be assessed by reviewing available standardized clinical, radiographic, and quality of life (QOL) criteria. The safety and tolerance will also be assessed by reviewing available plasma, urine, and brain tumor tissue for metabolites of the tumor and the effects of DCA thereon.

Conditions Studied

Interventions

  • DRUG Dichloroacetate

Study Locations (1)

Florida

  • University of Florida - Gainesville

Trial Details

FieldValue
Enrollment Target 15 participants
Start Date 2010-04
Est. Completion 2014-03
Phase Phase 1
University of Florida

1,106 total trials

What the finished NCT01111097 record still lists

NCT01111097 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 109-participant average among 199 other Glioblastoma trials with a reported enrollment target (86% lower).

The record links to 2 conditions, with Glioblastoma appearing as the primary indexed condition, and to 1 intervention - of which Dichloroacetate is the first listed.

NCT01111097 reports a single indexed study location in Florida.

Frequently Asked Questions

What is clinical trial NCT01111097 about?

NCT01111097 is a clinical study titled "Study of the Safety and Efficacy of Dichloroacetate (DCA) in Glioblastoma and Other Recurrent Brain Tumors". The purpose of this study is to evaluate the safety and tolerability of oral Dichloroacetate (DCA) in the treatment of recurrent malignant brain tumors (RMBTs). RMBTs are defined as either: 1) malignant tumors, originating in the brain, that have recurred at least once or 2) malignant tumors origina...

What is the current status of trial NCT01111097?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 15 participants. The study started on 2010-04. Estimated completion is 2014-03.

What conditions does trial NCT01111097 study?

This clinical trial studies the following conditions: Glioblastoma, Brain Tumor.

What interventions are being tested in trial NCT01111097?

The interventions under investigation include: Dichloroacetate (DRUG).

Who is sponsoring clinical trial NCT01111097?

This trial is sponsored by University of Florida, which has 1,106 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01111097 being conducted?

This trial has 1 study location across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Glioblastoma

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT01111097's enrollment target sits among peer trials

15 172nd of 199 higher than 25 of 199 other Glioblastoma trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Glioblastoma 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 NCT01111097, the US trial registry maintained by the National Library of Medicine. NCT01111097 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.