A phase II study of temsirolimus and bevacizumab in recurrent glioblastoma multiforme
- Conditions
- Glioblastoma multiforme and progression after prior VEGF-directed therapyMedDRA version: 9.1Level: LLTClassification code 10018337Term: Glioblastoma multiforme
- Registration Number
- EUCTR2008-003679-40-DK
- Lead Sponsor
- Rigshospitalet
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 32
-Written informed consent
-Histological verification of primary GBM and failure after radiotherapy and temozolomide (TMZ) previously treated with VEGF-directed therapy with bevacizumab
-Previously received radiotherapy and temozolomide
-More than 4 weeks since any of the following prior treatments:
a: Chemotherapy (6 weeks for nitrosoureas or mitomycin C)
b: Radiotherapy to nontarget lesions or lesions that are not to be biopsied
c: VEGF-directed therapy (including bevacizumab)
d: Investigational agents
-More than 6 months since prior major surgery or open biopsy and recovered (only 6 weeks required if operation is for recurrent GBM)
-No concurrent medications or substances known to affect or with the potential to affect the activity or pharmacokinetics of the following (with exception to enzyme-inducing anti-epileptic drugs, please see dosage adjustment for temsirolimus page 10):
a: Temsirolimus
b: Bevacizumab
c: CYP450 isoenzymes
-ECOG performance status 0-1
-WBC = 3,000 mm³
-Absolute neutrophil count = 1,500/mm³
-Platelet count = 100,000/mm³
-Bilirubin normal
-AST and ALT = 2.5 times upper limit of normal
-Creatinine normal OR creatinine clearance = 60 mL/min
-Urine protein:creatinine ratio < 1.0 OR 24-hour urine protein < 1,000 mg
-Fasting cholesterol < 350 mg/dL (cholesterol medications are allowed)
-Fasting triglycerides < 400 mg/dL
-PT INR = 1.5
-Hematocrit < 41% (for males) or < 38% (for females)
-Fertile females must use oral contraceptive, IUD (intrauterine device) or preservatives.
-Fertile males must use preservatives.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Clinically significant cardiovascular disease, including the following:
-Cerebrovascular accident within the past 6 months
-Transient ischemic attack within the past 6 months
-Myocardial ischemia within the past 6 months
-Myocardial infarction within the past 6 months
-Other thromboembolic event within the past 6 months
-Unstable angina within the past 6 months
-Uncontrolled hypertension (i.e., hypertension despite maximal therapy)
-New York Heart Association class II-IV heart disease
-Congestive heart failure
-Serious cardiac arrhythmia requiring medication
-Clinically significant peripheral vascular disease
-Uncontrolled intercurrent illness
-Ongoing or active infection
One of the following within the past 6 months:
a: Abdominal fistula
b. astrointestinal perforation
c: Intra-abdominal abscess
d Serious or nonhealing wound, ulcer, or bone fracture
-Psychiatric illness or social situations that would preclude study compliance
-Uncontrolled diabetes
-Hemoglobin A1c > 7%
-Concurrent nonstudy-related surgical procedures
-Other concurrent anticancer agents or therapies
-Significant traumatic injury within the past 28 days
-History of allergic reactions to compounds of similar chemical or biological composition to temsirolimus or bevacizumab
-Hypersensitivity to Chinese hamster ovary cell products or other recombinant human antibodies (e.g., infliximab)
-Pregnancy or nursing
-Patients previously intolerant to bevacizumab
-Anticoagulant therapy
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