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

NCT ID: NCT02029573

Last Updated: 2017-08-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-01-01
• Study Completion Date: 2016-12-31

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.

Conditions

Glioblastoma Multiforme

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Atorvastatin in Combination With Radiotherapy and Temozolomide

Group Type: EXPERIMENTAL

Atorvastatin

Intervention Type: DRUG

80 mg po daily until disease progression or unacceptable toxicity. (starting dose of 40 mg po daily for the first 21 days)

Temozolomide

Intervention Type: DRUG

75mg/m2 po daily during radiotherapy, followed by 150-200mg/m2/day po on days 1-5 of each 6x4 week cycle of adjuvant therapy

Radiotherapy

Intervention Type: RADIATION

60 Gy in 30 fractions

Interventions

Atorvastatin

80 mg po daily until disease progression or unacceptable toxicity. (starting dose of 40 mg po daily for the first 21 days)

Intervention Type: DRUG

Temozolomide

75mg/m2 po daily during radiotherapy, followed by 150-200mg/m2/day po on days 1-5 of each 6x4 week cycle of adjuvant therapy

Intervention Type: DRUG

Radiotherapy

60 Gy in 30 fractions

Intervention Type: RADIATION

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

King Fahad Medical City

OTHER_GOV

Sponsor Role: lead

Responsible Party

Abdullah Khalaf Altwairgi

Medical Oncologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Abdullah K. Altwairgi, MD

Role: STUDY_CHAIR

King Fahad Medical City

Locations

King Fahad Medical City

Riyadh, , Saudi Arabia

Countries

Saudi Arabia

Other Identifiers

KFMC-CNS-01

Identifier Type: -

Identifier Source: org_study_id