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A Phase II Study of Temsirolimus and Bevacizumab in Recurrent Glioblastoma Multiforme

Phase 2
18 Years
Not Enrolling
Glioblastoma Multiforme

Thank you

Trial Information

A Phase II Study of Temsirolimus and Bevacizumab in Recurrent Glioblastoma Multiforme

Inclusion Criteria:

- 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 Criteria:

- 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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression-free survival in months

Outcome Time Frame:

From start of treatment to death or progression

Safety Issue:



Denmark: The Danish National Committee on Biomedical Research Ethics

Study ID:




Start Date:

November 2008

Completion Date:

February 2010

Related Keywords:

  • Glioblastoma Multiforme
  • Glioblastoma