Comparing Etoposide with Tamoxifen for glioblastoma multiforme

Inclusion

• +ECOG performance 0-2 (Appendix 2).
• +Age from 18-65 years.
• +Histologically proven GBM with progression after previous first line chemoradiotherapy with temozolomide.
• +Progression documented by MRI with at least one bi-dimensionally measurable target lesion with one diameter of at least 10 mm, visible on two or more axial slices 5 mm apart.
• +Not received radiotherapy within the three months before the diagnosis of progression.
• +Stable or decreasing dose of corticosteroids prior to randomizationRandomisedWhich group you go into is decided by chance, not by you or your doctor.Read more →: corticosteroids (dexamethasone) should be given at the lowest dose needed to controlControl groupThe group a new treatment is measured against.Read more → symptoms arising from increased intracerebral edema.
• +Laboratory evaluation obtained within 7 days prior to randomization, with adequate function as defined below:
• +ANC ≥ 1.5 x 109/L
• +Platelets ≥ 100 x 109/L
• +Serum creatinine ≤ 1.5 times ULN
• +Total serum bilirubin ≤ 1.5 times ULN
• +ALT \< 3 times ULN
• +AST \< 3 times ULN
• +Alkaline phosphatase \< 3 times ULN
• +Patient must understand and sign an informed consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more → prior to study registration.
• +Women of child bearing potential (WOCBP) must have a negative serum (or urine) pregnancy test within 72 hours prior to the first dose of study treatment. WOCBP is defined as any female who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy or bilateral salpingectomy) and is not postmenopausal. Menopause is defined as 12 months of amenorrhea in a woman over age 45 years in the absence of other biological or physiological causes.
• +Patients of childbearing / reproductive potential should use adequate birth control methods, as defined by the investigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more →, during the study treatment period and for a period of 60 days after the last dose of study drug. A highly effective method of birth control is defined as those that result in low failure rate (i.e. less than 1% per year) when used consistently and correctly.
• +Note: abstinence is acceptable if this is established and preferred contraception for the patient and is accepted as a local standard.