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Chloroquine for Glioblastoma.

Primary Purpose

Glioblastoma

Status
Unknown status
Phase
Phase 1
Locations
Egypt
Study Type
Interventional
Intervention
Oral tablet
Placebo
Sponsored by
Egyptian Medical Syndicate
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Glioblastoma

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Private clinics

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Chloroquine group

Placebo drug group

Arm Description

Outcomes

Primary Outcome Measures

Survival duration after surgery

Secondary Outcome Measures

End-point evaluation, survival at three years

Full Information

First Posted
February 24, 2021
Last Updated
February 25, 2021
Sponsor
Egyptian Medical Syndicate
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1. Study Identification

Unique Protocol Identification Number
NCT04772846
Brief Title
Chloroquine for Glioblastoma.
Official Title
Adjuvant Chloroquine to the Conventional Treatment for Glioblastoma.
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Unknown status
Study Start Date
March 1, 2018 (Actual)
Primary Completion Date
December 1, 2020 (Actual)
Study Completion Date
March 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Egyptian Medical Syndicate

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glioblastoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
Care Provider
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Chloroquine group
Arm Type
Experimental
Arm Title
Placebo drug group
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Oral tablet
Intervention Description
Oral 250mg chloroquine tablets
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Oral placebo tablets
Primary Outcome Measure Information:
Title
Survival duration after surgery
Time Frame
Three years
Secondary Outcome Measure Information:
Title
End-point evaluation, survival at three years
Time Frame
Three years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Private clinics
City
Cairo
ZIP/Postal Code
12613
Country
Egypt

12. IPD Sharing Statement

Learn more about this trial

Chloroquine for Glioblastoma.

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