Clinical trial NCT02029573: Efficacy and Safety of Atorvastatin in Combination With Radiotherapy and Temozolomide in Glioblastoma
Official title: Phase II Study of Atorvastatin in Combination With Radiotherapy and Temozolomide in Glioblastoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Glioblastoma Multiforme
Keywords: Phase II
Atorvastatin
Temozolomide
Radiotherapy
Glioblastoma Multiforme (GBM)
Lead sponsor: King Fahad Medical City
Sponsor class: OTHER_GOV
First posted: 2014-01-08
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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 criteria: 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.
* Protocol treatment is to begin within 10 working days of patient registration.

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.

Primary outcomes:
measure: Progression free survival at 6 months (PFS-6)
timeFrame: up to 6 months
Secondary outcomes:
measure: Progression free survival
timeFrame: Up to 2-3 years
measure: Overall Survival (OS)
timeFrame: Up to 2-3 years
measure: Adverse events
timeFrame: Up to 2-3 years
Other outcomes:
Locations:
city: Riyadh
country: Saudi Arabia
facility: King Fahad Medical City
Study officials:
affiliation: King Fahad Medical City
name: Abdullah K. Altwairgi, MD
role: STUDY_CHAIR
References: