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NCT04397679 · ClinicalTrials.gov registry record · Phase 1

Partial Brain RT, Temozolomide, Chloroquine, and TTF Therapy for the Treatment of Newly Diagnosed Glioblastoma

A Phase 1 study, sponsored by Barbara Ann Karmanos Cancer Institute.

Terminated
Registry status
Phase 1
Development phase
2
Enrollment target

NCT04397679: Clinical Trial Phase 1 study, sponsored by Barbara Ann Karmanos Cancer Institute.

NCT04397679 is a Phase 1 study that was terminated before completion, run by Barbara Ann Karmanos Cancer Institute. The registered enrollment target is 2 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04397679, a Phase 1 study, was terminated before completion, sponsored by Barbara Ann Karmanos Cancer Institute.

TERMINATED
Registry status
Phase 1
Development phase
2 participants
Enrollment target

Study Summary

This trial studies the side effects of partial brain radiation therapy, temozolomide, chloroquine, and tumor treating fields therapy for the treatment of newly diagnosed glioblastoma. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Chemotherapy drugs, 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. Chloroquine is normally used to treat strains of malaria and prior preclinical and clinical data suggests that it may increase the efficacy of both radiation and tumor treating fields therapy. Tumor treating fields therapy uses electric fields tuned to specific frequencies to disrupt cell division, inhibiting tumor growth and potentially causing cancer cells to die. The purpose of this study is to determine the safety of partial brain radiation therapy, temozolomide, chloroquine, and tumor treating fields therapy in patients with gliobastoma

Primary Outcome

Will summarize dermatitis status

Interventions

  • DRUG Temozolomide
  • RADIATION Intensity-Modulated Radiation Therapy (IMRT)
  • RADIATION 3-Dimensional Conformal Radiation Therapy
  • DRUG Chloroquine
  • PROCEDURE Tumor Treating Fields Therapy (TTF)

Trial Details

FieldValue
Enrollment Target 2 participants
Start Date 2021-08-12
Est. Completion 2024-05-14
Phase Phase 1

Why NCT04397679 stopped before completion

NCT04397679 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 2 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (97% lower).

The record links to 0 conditions, and to 5 interventions - of which Temozolomide is the first listed.

NCT04397679 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT04397679 about?

NCT04397679 is a clinical study titled "Partial Brain RT, Temozolomide, Chloroquine, and TTF Therapy for the Treatment of Newly Diagnosed Glioblastoma". This trial studies the side effects of partial brain radiation therapy, temozolomide, chloroquine, and tumor treating fields therapy for the treatment of newly diagnosed glioblastoma. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Chemotherapy drugs, such as temozol...

What is the current status of trial NCT04397679?

This trial is currently terminated. It is a Phase 1 study. The enrollment target is 2 participants. The study started on 2021-08-12. Estimated completion is 2024-05-14.

What interventions are being tested in trial NCT04397679?

The interventions under investigation include: Temozolomide (DRUG), Intensity-Modulated Radiation Therapy (IMRT) (RADIATION), 3-Dimensional Conformal Radiation Therapy (RADIATION), Chloroquine (DRUG), Tumor Treating Fields Therapy (TTF) (PROCEDURE).

Who is sponsoring clinical trial NCT04397679?

This trial is sponsored by Barbara Ann Karmanos Cancer Institute, which has 139 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT04397679's enrollment target sits among peer trials

2 2000th of 2000 the lowest 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 NCT04397679, the US trial registry maintained by the National Library of Medicine. NCT04397679 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.