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NCT00486603 · ClinicalTrials.gov registry record · Phase 1

Hydroxychloroquine, Radiation, and Temozolomide Treating Patients With Newly Diagnosed Glioblastoma Multiforme

A Phase 1 study of Brain and Central Nervous System Tumors, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.

Completed
Registry status
Phase 1
Development phase
92
Enrollment target
9
Study locations

NCT00486603 is a Phase 1 study of Brain and Central Nervous System Tumors that has completed, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins. The registered enrollment target is 92 participants, below the 182-participant average among 45 other Brain and Central Nervous System Tumors trials with a reported enrollment target (49% lower). The trial reports 9 study locations across 9 states.

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The verdict

NCT00486603, a Phase 1 study of Brain and Central Nervous System Tumors, has completed, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.

COMPLETED
Registry status
Phase 1
Development phase
92 participants
Enrollment target
9
Study locations

Study Summary

RATIONALE: Drugs used in chemotherapy, such as hydroxychloroquine and temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving hydroxychloroquine together with temozolomide and radiation therapy may kill more tumor cells. PURPOSE: This phase I/II trial is studying the side effects and best dose of hydroxychloroquine when given together with radiation therapy and temozolomide and to see how well they work in treating patients with newly diagnosed glioblastoma multiforme.

Interventions

  • RADIATION Radiation
  • DRUG temozolomide
  • OTHER pharmacological study
  • DRUG hydroxychloroquine

Study Locations (9)

Alabama

  • University of Alabama at Birmingham Comprehensive Cancer Center - Birmingham

Florida

  • H. Lee Moffitt Cancer Center and Research Institute at University of South Florida - Tampa

Georgia

  • Winship Cancer Institute of Emory University - Atlanta

Maryland

  • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins - Baltimore

Massachusetts

  • Massachusetts General Hospital - Boston

Michigan

  • Josephine Ford Cancer Center at Henry Ford Hospital - Detroit

North Carolina

  • Wake Forest University Comprehensive Cancer Center - Winston-Salem

Ohio

  • Case Comprehensive Cancer Center - Cleveland

Trial Details

FieldValue
Enrollment Target 92 participants
Start Date 2007-10-29
Est. Completion 2014-01
Phase Phase 1

What the Registry Record Tells You About NCT00486603

The ClinicalTrials.gov registry entry for NCT00486603 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 92 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 182-participant average among 45 other Brain and Central Nervous System Tumors trials with a reported enrollment target (49% lower). The listed sponsor is Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, which has 523 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Brain and Central Nervous System Tumors appearing as the primary indexed condition, and to 4 interventions - of which Radiation is the first listed.

NCT00486603 reports 9 study locations spanning 9 distinct geographic areas - top geographies include Alabama, Florida, Georgia.

Frequently Asked Questions

What is clinical trial NCT00486603 about?

NCT00486603 is a clinical study titled "Hydroxychloroquine, Radiation, and Temozolomide Treating Patients With Newly Diagnosed Glioblastoma Multiforme". RATIONALE: Drugs used in chemotherapy, such as hydroxychloroquine and temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving hydroxychloroquine togeth...

What is the current status of trial NCT00486603?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 92 participants. The study started on 2007-10-29. Estimated completion is 2014-01.

What conditions does trial NCT00486603 study?

This clinical trial studies the following conditions: Brain and Central Nervous System Tumors.

What interventions are being tested in trial NCT00486603?

The interventions under investigation include: Radiation (RADIATION), temozolomide (DRUG), pharmacological study (OTHER), hydroxychloroquine (DRUG).

Who is sponsoring clinical trial NCT00486603?

This trial is sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, which has 523 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00486603 being conducted?

This trial has 9 study locations across Alabama, Florida, Georgia, Maryland, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.