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Efficacy and Safety of Atorvastatin in Combination With Radiotherapy and Temozolomide in Glioblastoma | Clinical Trials | Clareo Health

COMPLETEDPHASE2

Efficacy and Safety of Atorvastatin in Combination With Radiotherapy and Temozolomide in Glioblastoma

Phase II Study of Atorvastatin in Combination With Radiotherapy and Temozolomide in Glioblastoma

NCT02029573•King Fahad Medical City

View on ClinicalTrials.gov

Summary

The purpose of this study is to explore the efficacy and safety of Atorvastatin in combination with multimodality therapy of concurrent radiotherapy plus temozolomide followed by adjuvant temozolomide in patients with newly diagnosed glioblastoma multiforme (GBM).The anticipated time on study treatment is until disease progression, and the target sample size is 32 individuals.

Eligibility

Age

18 - 70 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Histologically proven newly diagnosed Malignant Glioblastoma Multiforme or variants (gliosarcoma, glioblastoma with oligodendroglial features, giant cell glioblastoma).
•Age ≥ 18 years.
•Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2.
•Patients must have an estimated life expectancy of at least 12 weeks.
•No prior chemotherapy or radiotherapy.
•Stable dose of steroid for ≥ 14 days prior to registration.
•Patients must have adequate bone marrow function (e.g., hemoglobin ≥10 g/dl, absolute granulocyte count ≥ 1.5 x 109/L, and platelet count ≥100 x 109/L.
•Adequate liver function (SGPT, SGOT, and alkaline phosphatase ≤ 2.5 times upper limits of normals (ULN) and total bilirubin ≤1.5 x ULN), and adequate renal function (BUN or creatinine ≤1.5 X ULN) prior to starting therapy.
•Paraffin embedded tumour sample available for study.
•Patient consent must be obtained according to local Institutional requirements. The patient must sign the consent form prior to registration.
+1 more criteria

Exclusion Criteria

•Pregnant or lactating women; men and women of childbearing potential must agree to practice an effective method of birth control. Women of childbearing potential must have a negative pregnancy test performed within 14 days prior to registration.
•Concurrent treatment with other experimental drugs or anticancer therapy.
•Patients with a history of other malignancies, except: adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumours curatively treated with no evidence of disease for \> 5 years.
•Prior radiotherapy or systemic cytotoxic chemotherapy .
•Severe, active co-morbidity, defined as follows: Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration, Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or oxygen, Hepatic insufficiency or Active liver disease resulting in clinical jaundice and/or coagulation defects, Acquired immune deficiency syndrome (AIDS) , Significant neurologic or psychiatric disorder which would impair the ability to obtain informed consent, Active uncontrolled or serious infection, active peptic ulcer disease, Any medical condition which could interfere with oral medication intake (e.g., frequent vomiting, partial bowel obstruction), Myocardial infarction within 6 months prior to registration, Congestive heart failure, unstable angina, active cardiomyopathy, cardiac arrhythmia, Skeletal muscle disease and other related reticule-endothelial diseases.
•Patients with known hypersensitivity to the study drugs or their components.

Locations (1)

King Fahad Medical City

Riyadh, Saudi Arabia

Key Dates

Start Date

January 1, 2014

Primary Completion Date

December 31, 2016

Completion Date

December 31, 2016

Last Updated

August 18, 2017

Enrollment

ACTUAL participants

Conditions

Glioblastoma Multiforme

Interventions

Atorvastatin

DRUG

Temozolomide

DRUG

Radiotherapy

RADIATION

Targeted Pediatric High-Grade Glioma Therapy

NCT05839379

High Grade GliomaDiffuse Intrinsic Pontine Glioma+7 more

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RECRUITING

Collection of Blood and Urine Samples in Patients Receiving Radiation Therapy for Glioblastoma Multiforme

NCT00083512

Glioblastoma Multiforme

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 18, 2017Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Efficacy and Safety of Atorvastatin in Combination With Radiotherapy and Temozolomide in Glioblastoma

Inclusion Criteria

Exclusion Criteria

Targeted Pediatric High-Grade Glioma Therapy

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