Status:
COMPLETED
A Study of Temsirolimus and Bevacizumab in Recurrent Glioblastoma Multiforme
Lead Sponsor:
Rigshospitalet, Denmark
Collaborating Sponsors:
University of Copenhagen
Wyeth is now a wholly owned subsidiary of Pfizer
Conditions:
Glioblastoma Multiforme
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This trial is an investigator initiated, open label phase II study, where patient with recurrent primary GBM will be considered for the study. Only patients with recurrence after Temozolomide and VEGF...
Eligibility Criteria
Inclusion
- 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: chemotherapy (6 weeks for nitrosoureas or mitomycin C)
- Radiotherapy to nontarget lesions or lesions that are not to be biopsied VEGF-directed therapy (including bevacizumab)
- 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:
- Temsirolimus
- Bevacizumab
- CYP450 isoenzymes
- ECOG performance status 0-1
- WBC ≥ 3,000 mm³
- Absolute neutrophil count ≥ 1,500/mm³
- Platelet count ≥ 100,000/mm³
- Bilirubin and phosphate 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 an approved contraceptive (p-pills, IUD, depot injection of gestagen, subdermal implantation, hormonal vaginal ring or transdermal depot plaster), throughout the study and 3 months after discontinuation of study drugs. Fertile men must use dobbelt barrier method (preservative with sperm inhibiting creme) or female partner uses the above mentioned contraceptive.
- Fertile males must use preservatives.
Exclusion
- 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
- Abdominal fistula
- Gastrointestinal perforation
- Intra-abdominal abscess
- Serious or nonhealing wound, ulcer, or bone fracture
- Psychiatric illness or social situations that would preclude study compliance
- Uncontrolled diabetes
- Hemoglobin A1c \> 7%
- Concurrent non-study related surgical procedures
- Concurrent treatment with CYP3A4 inducers or inhibitors
- 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
Key Trial Info
Start Date :
November 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2010
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT00800917
Start Date
November 1 2008
End Date
February 1 2010
Last Update
June 2 2010
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Rigshospitalet
Copenhagen, Denmark