SUNITINIB (SUTENT, SU11248) in Patients with Recurrent or Progressive Glioblastoma multiformeAn Academic Prospective Single-arm Phase II Clinical Trial including Translational Research Studies - Sunitinib in Patients with Glioblastoma multiforme
- Conditions
- Glioblastoma multiforme - WHO grade IV First progression/recurrenceMedDRA version: 9.1Level: LLTClassification code 10018337Term: Glioblastoma multiforme
- Registration Number
- EUCTR2007-002142-37-AT
- Lead Sponsor
- Medizinische Universität Innsbruck
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 70
[1]Patients present with a first recurrence or first progression of a histological confirmed primary supratentorial glioblastoma multiforme WHO Grade IV (Classification following WHO criteria). Note: Patients may be entered based on local pathology from the original diagnostic tumor specimen. For Translational Research Studies the original paraffin block - including sufficient tissue of the primary tumor - is required. Stereotactic biopsies or open biopsies of the primary GBM without sufficient tumor tissue are not feasible and the patients must not be enrolled in this study.
[2]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, following MRIs scans have to be performed:
An MRI within 2 weeks before surgery of a progressed GBM followed by an MRI within 48 hours after surgery
Note: If the 48-hour scan is performed more than 14 days prior to study enrollment, the scan needs to be repeated, however, the <48 hour MRI is the baseline scan
?Patients must be on a steroid dosage that has been stable for at least 5 days before MRI
Note: If the steroid dose is increased between the date of imaging and enrollment, a new baseline MRI is required on a stable steroid dosage of at least 5 days duration
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).
Note: Patients must be on a steroid dosage that has been stable for at least 5 days before MRI. If the steroid dose has increased between the date of imaging and enrollment, a new baseline MRI is required on a stable steroid dosage of at least 5 days duration.
[3]Resolution of all acute toxic effects of prior therapy to grade = 1
[4]Patients must have an ECOG performance status of 0-2 (
[5]Patients must be = 18 years and = 75 years of age, with a life expectancy of greater than 8 weeks
[6]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
[7]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
[8]Willingness and ability of the patient to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2
[9]The patient is active participant in another clinical trial.
[10]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)
[11]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)
[12]Significant Co-Morbidities at the 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
[13]Anticoagulation: Current treatment with therapeutic doses of Marcoumar / Sintrom excluding thrombosis prophylaxis with low dose Heparin.
[14]Antiepileptic Drugs: Concurrent use of EIADs within 2 weeks of study enrollment (patients must discontinue EIAD treatment = 14 days prior to study enrollment, refer to Section 4.2.2.2 and Protocol Attachment A.9)
[15]Pregnancy, Breastfeeding and Contraception
?Female patients who are pregnant or nursing
?Female patients of child-bearing age or male patients who are unwilling or unable to use adequate contraception to prevent pregnancy during the study.
Note: Female and male patients with reproductive potential must use an approved contraceptive method (i.e., birth control pills, intrauterine device [IUD], or barrier device) during and for 3 months after discontinuation of study treatment. Female Patients with child-bearing age must have a negative serum pregnancy test = 3 days prior to study enrollment. During study treatment pregnancy has to be excluded (serum pregnancy tests every 2 weeks until tumor progression).
[16]Evidence of increased intracranial pressure
?midline shift > 5 mm
?distinct nausea and vomiting
[17]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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method