Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:44 PM
Ignite Modification Date:
2025-12-24 @ 9:44 PM
NCT ID:
NCT02378532
Eligibility Criteria:
Inclusion Criteria:
* Histologically confirmed grade IV supratentorial astrocytoma (glioblastoma multiforme)
* Tumor tissue available for histopathological analysis (MGMT, EGFRvIII)
* Diagnosis must have been made by biopsy or resection ≤ 3 months prior to study entry
* 18 years or older
* Karnofsky performance status ≥ 70
* Absolute neutrophil count at least 1.5 x 109/L and platelets at least 100 x109/L
* Adequate renal function
* Adequate hepatic function
* absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule.
* Females must have negative results for pregnancy tests performed
* No breast feeding.
* If male, subject must be surgically sterile or practicing a method of contraception
Exclusion Criteria:
* Prior radiotherapy
* Prior chemotherapy
* Recent (\< 3 months) severe cardiac disease (NYHA class \>1) (congestive heart failure, infarction)
* History of cardiac arrythmia (multifocal premature ventricular contractions, uncontrolled atrial fibrillation, bigeminy, trigeminy, ventricular tachycardia) which is symptomatic and requiring treatment (CTC AE 4.0), or asymptomatic sustained ventricular tachycardia. Asymptomatic atrial fibrillation controlled on medication is allowed.
* Cardiac conduction disturbances or medication potentially causing them
* Treatment with investigational drugs in 4 weeks prior to or during this study
* If the subject has clinically significant and uncontrolled major medical condition(s) including but not limited to:
* uncontrolled nausea/vomiting/diarrhea:
* active uncontrolled infection, including HIV and hepatitis (HBV, HCV)
* psychiatric illness/social situation that would limit compliance with study requirements
* any medical condition, with the opinion of the study investigator, places the subject at an unacceptably high risk for toxicities.
* The subject has had another active malignancy within the past 3 years except for any cancer in situ that the principal Investigator considers to be cured.
* Chronic systemic immune therapy (with the exception of corticosteroids)
* Concurrent cytochrome P450 enzyme-inducing anticonvulsant drugs (e.g., phenytoin, carbamazepine, phenobarbital, primidone, or oxcarbazepine)
* Known glucose-6-phosphate dehydrogenase deficiency
* Psoriasis or porphyria
* Known hypersensitivity to 4-aminoquinoline compound
* Retinal or visual field changes unrelated to the tumor location prior to 4-aminoquinoline compound use
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02378532
Study Brief:
Protocol Section:
NCT02378532