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Chloroquine for Glioblastoma.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04772846
Recruitment Status : Active, not recruiting
First Posted : February 26, 2021
Last Update Posted : February 26, 2021
Sponsor:
Information provided by (Responsible Party):
Mohammed A. Azab, Cairo University

Study Description
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Brief Summary:
Adjuvant chloroquine to the conventional treatment for glioblastoma; A randomized, single-blind, placebo-controlled, phase I/II trial.

Condition or disease Intervention/treatment Phase
Glioblastoma Drug: Oral tablet Drug: Placebo Phase 1 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Care Provider)
Primary Purpose: Treatment
Official Title: Adjuvant Chloroquine to the Conventional Treatment for Glioblastoma.
Actual Study Start Date : March 1, 2018
Actual Primary Completion Date : December 1, 2020
Estimated Study Completion Date : March 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Chloroquine group Drug: Oral tablet
Oral 250mg chloroquine tablets
Placebo Comparator: Placebo drug group Drug: Placebo
Oral placebo tablets


Outcome Measures
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Primary Outcome Measures :
  1. Survival duration after surgery [ Time Frame: Three years ]

Secondary Outcome Measures :
  1. End-point evaluation, survival at three years [ Time Frame: Three years ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Histologically confirmed glioblastoma Adequate hematologic, hepatic, and renal function Karnofsky performance status score ≥ 70% Life expectancy ≥ six weeks

Exclusion Criteria:

Abnormal severe un-controlled medical conditions

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04772846


Locations
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Egypt
Private clinics
Cairo, Egypt, 12613
Sponsors and Collaborators
Egyptian Medical Syndicate
More Information
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Responsible Party: Mohammed A. Azab, Department of Neurosurgery, Cairo University
ClinicalTrials.gov Identifier: NCT04772846    
Other Study ID Numbers: CQGBM
First Posted: February 26, 2021    Key Record Dates
Last Update Posted: February 26, 2021
Last Verified: February 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Glioblastoma
Astrocytoma
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
 Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue