patients affected by GBM MedDRA version: 9.1 Level: LLT Classification code 10018337
Conditions
Interventions
Trade Name: TEMODAL
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Temozolomide
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-
Trade Name: TEMODAL
P
Sponsors
FONDAZIONE CENTRO S. RAFFAELE DEL MONTE TABOR
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -C.I. firmato orima di sottoporsi a qualsiasi procedura;eta` compresa tra i 18 e i 70 anni; nuova diagnosi istologica di GBM; etc. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria:  Patient who can not comply with planned protocols procedures  Prior chemotherapy within the last 5 years  Prior RT of the head  Receiving concurrent investigational agents or has received an investigational agent  Prior anti-angiogenic therapy  Placement of Gliadel? wafer at surgery  Planned surgery for other diseases  History of malignancy. Subjects with curatively treated cervical carcinoma in situ or basal cell carcinoma of the skin, or subjects who have been free of other malignancies for more than 5 years are eligible for this study  Any uncontrolled intercurrent illness (e.g. high blood pressure, unstable angina, serious cardiac arrhythmia, diabetes ), also including severe infection, which may jeopardize the ability of the subject to receive the procedures outlined in this protocol with reasonable safety  Subject is pregnant (positive pregnancy test [serum -HCG] at screening), or is currently breast-feeding  Any psychological, familiar, sociological, legal or geographical state that could potentially interfere with the study protocol compliance; these conditions should be evaluated before patients enrolment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: to identify a serum proteomic profile in patients with newly diagnosed glioblastoma multiforme treated with standard therapy.;Secondary Objective: to identify a serum proteomic profile in patients with newly diagnosed glioblastoma multiforme treated with standard therapy.;Primary end point(s): Correlation between proteomic profile and outcome, in terms of PFS and OS of patients with GBM treated with standard therapy | — |
Countries
Italy
Outcome results
None listed