Clinical trial NCT00535379 (phase 2, status: unknown status)
Conditions: glioblastoma multiforme
ICD codes: L51.0, L51.8, L51.9
Drugs: sunitinib
SMILES: CNC(=O)C1=C(SC2=CC=C3C(NN=C3\C=C\C3=CC=CC=N3)=C2)C=CC=C1
Eligibility criteria:

        Inclusion Criteria:

          -  Patients present with a first recurrence or first progression of a histological
             confirmed primary supratentorial glioblastoma multiforme WHO Grade IV (Classification
             following WHO criteria).

          -  Patients with surgical resection of first tumor progression: Following standard
             therapy patients must have evidence of first tumor progression. In general, patients
             may have undergone prior surgical resection of the first tumor progression and will be
             eligible if the following conditions apply:

          -  Patients must have recovered from the effects of surgery

          -  To adequately asses the GBM before surgery and the extent of residual disease
             postoperatively, two MRIs scans have to be performed:

          -  The first MRI scan within 2 weeks before surgery to document a progressed or recurrent
             GBM. The second MRI scan within 48 hours after surgery.

          -  Patients without surgical resection of first tumor progression:

          -  Patients must have evidence of first tumor progression following standard therapy as
             measured by a baseline MRI within 2 weeks prior to study enrollment (Macdonald
             criteria: i.e. tumor growth > 25% or new lesion).

          -  Resolution of all acute toxic effects of prior therapy to grade ≤ 1 (except alopecia)

          -  Patients must have an ECOG performance status of 0-2

          -  Patients must be ≥ 18 years and ≤ 75 years of age, with a life expectancy of greater
             than 8 weeks

          -  Patients must have adequate organ function as defined by the following criteria:

        Bone Marrow Reserve - Platelets ≥ 75.000/μL

          -  Absolute Neutrophil Count (ANC) ≥ 1500/μL

          -  Hemoglobin ≥ 10.0 g/dL Blood Coagulation - aPTT ≤ 1.5 times upper limit of normal
             (ULN) Hepatic Function - ASAT and ALAT ≤ 1.5 times ULN

          -  ALP ≤ 2.5 times ULN

          -  Total Serum Bilirubin < 1 times ULN Renal Function - Serum Creatinine ≤ 1.5 times ULN
             Metabolism - Serum Albumin ≥ 3.0 g/dL Heart Function - Left Ventricular Ejection
             Fraction (LVEF) ≥ 50% as measured by transthoracic echocardiogram ECHO) All tests must
             be performed ≤ 3 days prior to study enrollment. Eligibility for hemoglobin count may
             be reached by transfusion

          -  Signed and dated informed consent document by the patient, indicating that the patient
             has been informed of all the pertinent aspects of the trial prior to study enrollment

          -  Willingness and ability of the patient to comply with scheduled visits, treatment
             plans, laboratory tests, and other study procedures

        Exclusion Criteria:

          -  The patient is active participant in another clinical trial.

          -  Exclusion of patients in the event of

               -  surgery for recurrence/progression within 1 week prior to study enrollment

               -  chemotherapy within 4 weeks prior to study enrollment

               -  treatment with more than one chemotherapy regime

               -  radiation therapy within 8 weeks to study enrollment

               -  evidence in baseline MRI of intratumoral or peritumoral hemorrhage deemed
                  clinically significant by the treating physician (area of hemorrhage > 25% of
                  tumor area)

          -  Significant Co-Morbidities within 12 months prior to study enrollment

               -  myocardial infarction, severe/unstable angina pectoris, coronary/peripheral
                  artery bypass graft, congestive heart failure

               -  pulmonary embolus

               -  cerebro-vascular accident including TIA (transient ischemic attack)

          -  Significant Co-Morbidities at Baseline Evaluation

               -  Clinically significant ongoing cardiac dysrhythmias of grade ≥ 2, atrial
                  fibrillation of any grade, QTc interval > 470 ms measured by electrocardiogram
                  (ECG)

               -  Hypertension that cannot be controlled by medications (>150/100 mmHg despite
                  optimal medical therapy)

               -  A known HIV (human immunodeficiency virus) or Hepatitis B/C infection or severe
                  acute infection

          -  Anticoagulation: Current treatment with therapeutic doses of Marcoumar / Sintrom
             excluding thrombosis prophylaxis with low dose Heparin.

          -  Antiepileptic Drugs: Concurrent use of EIADs within 2 weeks of study enrollment
             (patients must discontinue EIAD treatment ≥ 14 days prior to study enrollment)

          -  Pregnancy, Breastfeeding and Non-Contraception

               -  Female patients who are pregnant or nursing

               -  Patients who are sexually active and unwilling or unable to use a medically
                  acceptable method of contraception during the trial.

          -  Evidence of increased intracranial pressure

               -  midline shift > 5 mm

               -  distinct nausea and vomiting

          -  Other severe acute or chronic medical or psychiatric condition or laboratory
             abnormality that would impart excess risk associated with study participation or study
             drug administration, or which would make the patient inappropriate for entry into this
             study. The decision to enroll the patient in this study is in the judgment of the
             investigator.