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

NCT02029573 | Completed Phase 2 DMC

• 1 other identifier: KFMC-CNS-01
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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

Keywords

Phase II; Atorvastatin; Temozolomide; Radiotherapy; Glioblastoma Multiforme (GBM)

Outcome Measures

Primary Outcomes (1)

• Progression free survival at 6 months (PFS-6)

  All efficacy determinations will be based on the Response Assessment in Neuro-Oncology (RANO) response criteria (Wen 2010)

  up to 6 months

Secondary Outcomes (3)

• Progression free survival

  Up to 2-3 years

• Overall Survival (OS)

  Up to 2-3 years

• Adverse events

  Up to 2-3 years

Study Arms (1)

Atorvastatin in Combination With Radiotherapy and Temozolomide

EXPERIMENTAL

Drug: Atorvastatin; Drug: Temozolomide; Radiation: Radiotherapy

Interventions

Atorvastatin DRUG

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

Atorvastatin in Combination With Radiotherapy and Temozolomide

Temozolomide 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

Atorvastatin in Combination With Radiotherapy and Temozolomide

Radiotherapy RADIATION

60 Gy in 30 fractions

Atorvastatin in Combination With Radiotherapy and Temozolomide

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• King Fahad Medical City: lead

Study Sites (1)

King Fahad Medical City

Riyadh, 11525, Saudi Arabia

Location

MeSH Terms

Conditions

Glioblastoma

Interventions

Atorvastatin; Temozolomide; Radiotherapy

Condition Hierarchy (Ancestors)

Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heptanoic Acids; Fatty Acids; Lipids; Dacarbazine; Triazenes; Organic Chemicals; Imidazoles; Therapeutics

Study Officials

• Abdullah K. Altwairgi, MD

  King Fahad Medical City

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Oncologist

Study Record Dates

• First Submitted: January 3, 2014
• First Posted: January 8, 2014
• Study Start: January 1, 2014
• Primary Completion: December 31, 2016
• Study Completion: December 31, 2016
• Last Updated: August 18, 2017

Record last verified: 2017-08

Locations

SA (1)