Glioblastoma recurrent MedDRA version: 9.1 Level: LLT Classification code 10018336 Term: Glioblastoma
Conditions
Sponsors
ISTITUTO NEUROLOGICO "CARLO BESTA"
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the study: 1.Signed and dated IRB-approved Informed Consent. 2.Histologically proven (at diagnosis) Glioblastoma Multiforme (GBM) 3.Recurrence or progression after treatment with surgery, radiotherapy and chemotherapy, including temozolomide 4.Age more between 18 years 5.KPS 18 and 70 years enclosed 6.Life expectancy of at least 12 weeks 7.Negative pregnancy test (if female in reproductive age) 8.Agreement upon the use of effective contraceptive methods (hormonal or barrier method of birth control; or abstinence) prior to study entry and for the duration of study participation, if men and women of child-producing potential 9.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) 10.Acceptable renal function: Serum creatinine ≤1.5 mg/dl (or ≤133 µmol/L) 11.Acceptable hematologic status: - ANC  1,500 cells/mm3 - Platelet count  100,000 cells/mm3 - Hemoglobin  10.0 g/dL 12.At the time of first dose of study combination, at least 4 weeks must have elapsed since completion of prior temozolomide therapy, prior radiotherapy, prior surgery (at least 6 weeks since completion of prior nitrosurea therapy) 13.With the exception of alopecia, resolution of all acute toxic effects of any prior surgery, radiotherapy, radiosurgery or chemotherapy to NCI CTC (Version 3.0) Grade =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: The presence of any of the following will exclude a subject from study enrollment: 1.Major surgery, other than diagnostic surgery, within 4 weeks prior to Day 1 2.Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy 3.Pregnant or breast feeding women 4.Known infection with HIV, active hepatitis B or hepatitis C 5.Prior high-dose chemotherapy with bone marrow or stem cell support 6.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. 7.Current enrollment in another therapeutic clinical trial 8.Patients who have exhibited allergic reactions to temozolomide or fotemustine 9.Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or may interfere with the interpretation of study results and, in the judgement of the investigator, would make the patient inappropriate for entry into this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The purpose of this single arm phase II study is to evaluate an alternating weekly regimen of temozolomide if and monthly fotemustine combination can significantly increase the progression free survival in the treatment of pre-treated, recurrent GBM patients.;Secondary Objective: Safety, Median Survival Time, RX responses;Primary end point(s): Progression Free Survival at 6 months (PFS-6) | — |
Countries
Italy
Outcome results
None listed