Refractory glioblastoma multiforme.
Conditions
Sponsors
Hellenic Cooperative Oncology Group
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion criteria:1. Written informed consent 2. Age ³18 years3. Radiographic evidence of recurrent glioma (Gr IV glioblastoma multiforme or Gr III anaplastic astrocytoma). Patients should have achieved CR, PR or SD with prior treatment with RT/ temozolomide (adjuvant or 1st line setting). Early recurrence patients may be included in the phase I study.4. Measurable disease at screening according to RECIST5. ECOG performance status (PS) 0-26. Adequate haematological function (ANC =1.5 x 109/L, Platelet count =100 x 109/L and Haemoglobin =9 g/dL)7. Adequate liver and renal function (Total bilirubin =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Exclusion criteria:1. Pregnant or lactating women2. Clinically significant non-controlled cardiovascular disease 3. Treatment with any other investigational agent, or participation in another clinical trial within 28 days prior to enrolment4. Prior treatment with EGFR inhibitors will not be allowed5. Known hypersensitivity to drugs chemically related to lapatinib 6. Evidence of any other disease, neurological or metabolic dysfunction, physical examination finding or laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or puts the patient at high risk for treatment-related complications7. Treatment with EIAEDs will be excluded, use of valproate will be permitted. 8. Patients will be excluded if unable to swallow tablets.9. Active infection.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Phase I:The main objective is to determine the maximum tolerated dose and recommended phase II dose of lapatinib when given in combination with temozolomide in patients with recurrent or refractory glioblastoma multiforme and to assess the safety, tolerability and toxicity profile of this regimen in these patients.Phase II:The primary objective is to evaluate the activity of lapatinib monotherapy in patients with recurrent high grade gliomas by determining possible metabolic changes in the brain.;Secondary Objective: Secondary objectives include the evaluation of Clinical Benefit (SD, PR and CR) of lapatinib OD treatment (monotherapy or combination with temozolomide), as assessed by RECIST criteria and volumetric measurements, as well as Time to disease progression (TTP), survival (OS), toxicity and biomarker analysis.;Primary end point(s): Metabolic changes in the brain of patients by SPECT/PET-CT scans. | — |
Countries
Greece
Outcome results
None listed