Glioblastoma multiforme MedDRA version: 8.1 Level: LLT Classification code 10018337 Term: Glioblastoma multiforme
Conditions
Interventions
Trade Name: Glivec Filmtabletten
Product Name: Glivec Filmtabletten
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Imatinib mesylate
CAS Number: 220127-57-1
Current Sponsor code: STI571
Sponsors
Novartis Pharma GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Patients must have newly diagnosed uni- or bilocular glioblastoma multiforme (GBM) WHO °IV following partial or complete tumor resection. The results of a biopsy alone are not sufficient for diagnosis. The diagnosis of primary malignant glioma must be histologically confirmed. The original tissue paraffin block for each patient must be available for central diagnostic review. • MRI finding after surgery: (T1w axial, contrast agent dose 0,2ml/kg body weight; within 48h/ max. 72 hours) No evidence of contrast agent-accumulating residual tumor Or Contrast agent-accumulating residual tumor with a (maximal) Diameter = 1,0 cm (RECIST) • Patients taking steroids: must have been on a stable dose for = 7 days • ECOG performance score ? 2 • Hemoglobin = 10g/dL (or hematocrit > 29%), ANC > 1,500 cells/l, platelets > 100,000 cells/l. • Serum creatinine =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Patients who have ever received previous imatinib for any duration prior to study entry • Patients with = grade 2 peripheral edema, or pulmonary or pericardial effusions or ascites of any grade. • Patients who have an excessive risk of an intracranial hemorrhagic event (defined by stroke within the prior 6 months, history of CNS (excluding post-operative grade 1) or intraocular bleed. • Patients who have any uncontrolled systemic infection. • Patients who have any concurrent severe and/or uncontrolled medical disease. • Patients with evidence of intra-tumor hemorrhage on pretreatment diagnostic imaging. • Patients who have had major surgery within 2 weeks prior to study entry, or who have not recovered from prior major surgery. • Patients who received chemotherapy prior to study start or other investigational agents (biological, immunotherapeutic or cytostatic agents) prior to study start. • Patients with an impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of imatinib • Patients who are taking Coumadin (warfarin sodium). • For the purposes of MRI imaging, patients with a pacemaker; ferromagnetic metal implants other than those approved as safe for use in MR scanners (e.g. some types of aneurysm clips, shrapnel); patients suffering from uncontrollable claustrophobia or physically unable to fit into the machine (e.g. obesity etc.). • Patients with another primary malignancy treated within the prior three years except excised squamous cell carcinomas of the skin and carcinoma in situ lesions of other organs which have been treated for cure. • Patients with a known history of Human Immunodeficiency Virus (HIV) seropositivity; testing for HIV is not required at study entry. • Patients who are considered by the investigator as unlikely to be able to be compliant with the study, take the study medications, travel for the necessary assessment visits, or have other medical conditions likely to interfere with the study assessments must not be entered onto the trial. • Patients who are not able to provide reliable informed consent and who do not have a legal representative for healthcare decisions on their behalf must not be entered onto the protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the maximum tolerated dose (MTD) and dose-limiting toxicities (DLT) of escalating doses of imatinib in combination with hydroxyurea (HU) plus initial radiotherapy (RT) after surgery in patients with newly diagnosed glioblastoma multiforme (GBM) who are receiving or who are not receiving EIACD in phase I.;Secondary Objective: 1. To characterize the safety and tolerability of imatinib in combination with HU plus initial RT after surgery, including acute and chronic toxicities, in these patient populations. 2. To characterize the single-dose and repeated-dose pharmacokinetic assessments of imatinib and HU combination therapy in these patient populations. 3. At MTD dose level expansion: • To evaluate preliminary efficacy (overall response rates [RR], duration of response, progression-free survival (PFS) at 6 month , and overall survival) in these patient populations (in phase II). ;Primary end point(s): Maximum tolerated dose (MTD) and dose-limiting toxicities (DLT) of escalating doses of imatinib in combination with hydroxyurea plus initial radiotherapy. | — |
Countries
Germany
Outcome results
None listed