glioblastoma recurrent MedDRA version: 9.1 Level: LLT Classification code 10018336 Term: Glioblastoma
Conditions
Interventions
Trade Name: TEMODAL*1FL 5CPS 20MG
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Temozolomide
Concentration unit: mg/g milligram(s)/gram
Concentration type: equal
Concentration number: 20-
T
Sponsors
ISTITUTO NEUROLOGICO "CARLO BESTA"
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Signed and dated IRB-approved Informed Consent. Supratentorial, single tumor, without radiological signs of leptomeningeal diffusion. Histologically proven Glioblastoma Multiforme (GBM) following maximal resection of tumor ( ≥ 95%). Age ≥ 18 years KPS ≥ 70 Life expectancy of at least 3 months. Negative pregnancy test (if female in reproductive years) Agreement upon the use of effective contraceptive methods (hormonal or barrier method of birth control; or abstinence) prior to study entry and for the entire duration of study participation, if men and women with child-producing potential. Acceptable liver function: - Bilirubin  1.5 upper limit of normal (ULN) - Albumin  3.0 g/dL - AST (SGOT), ALT (SGPT)  2.5 ULN (if liver metastases are present, then  5 ULN is allowed) - Alkaline phosphatase  2.5 ULN (if liver and/or bone metastases are present, then  5 ULN is allowed) Acceptable renal function: Serum creatinine ≤1.5 mg/dl (or ≤133 µmol/L) Acceptable hematologic status: - ANC  1,500 cells/mm3 - Platelet count  100,000 cells/mm3 - Hemoglobin  10.0 g/dL. All patients on treatment with anticonvulsants should continue the anticonvulsant therapy with non-enzyme-inducing anticonvulsants (non-EIACs). Able and willing to comply with scheduled visits, therapy plans, and laboratory tests required in this protocol. 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: Diagnosis different to glioblastoma or gliosarcoma. Proven Glioblastoma Multiforme (GBM) but with resection < of 95 % of tumor. Infratentorial and multifocal Glioblastoma. Glioblastoma with signs of leptomeningeal dissemination. Major surgery, other than diagnostic surgery, within 4 weeks prior to Day 1 Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy. Pregnant or breast feeding women. Known HIV infection, active hepatitis B or hepatitis C. Prior chemotherapy. Previous (within the last 5 years) or current malignancies at other sites, except for adequately treated basal cell or squamous cell skin cancer or in situ carcinoma of the cervix uteri. Current enrollment in another therapeutic clinical trial. Other severe acute or chronic medical or psychiatric condition or laboratory abnormalities that may increase the risk associated with study participation or may interfere with the interpretation of study results and, on the basis of the investigator judgement, would make the patient inappropriate for this study or could compromise protocol objectives.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the safety and efficacy of Gliadel and Temozolomide as adjunctive treatment with surgery and external beam radiotherapy in newly diagnosed glioblastoma patients;Secondary Objective: Toxicities, PFS, Median Survival Time;Primary end point(s): % progeession free survival at 12 months (%PFS-12) | — |
Countries
Italy
Outcome results
None listed