A Phase II Study of Bevacizumab Plus Temodar and Tarceva After Radiation Therapy and Temodar in Patients With Newly Diagnosed Glioblastoma or Gliosarcoma Who Are Stable Following Radiation
- Patients with histologically proven, non-progressive glioblastoma multiforme (GBM)
or gliosarcoma (GS) with stable disease immediately following XRT + TMZ. All
patients will receive Bevacizumab plus Tarceva and TMZ.
- Biopsy or resection must have been performed prior to RT + TMZ.
- No chemotherapy is allowed prior to starting RT + TMZ, including Gliadel Wafers.
- Patients will have started RT + TMZ prior to registration and study entry and are
eligible as long as they do not have progressive disease and can start Bevacizumab +
TMZ and Tarceva within 4 weeks after the completion of RT + TMZ. Patients MUST have
been treated with at least 54 Gy radiotherapy (60 Gy recommended) and MUST have
received Temodar concurrently with radiotherapy for eligibility for this study.
- Patients may or may not have measurable or evaluable disease on contrast MR imaging.
A post-radiotherapy MRI scan must document stable disease.
- Patients must be > 18 years old and with a life expectancy > 12 weeks.
- Patients must have a Karnofsky performance status of > 70.
- Patients must have adequate bone marrow function (WBC > 3,000/µl, ANC > 1,500/mm3,
platelet count of > 100,000/mm3, and hemoglobin > 10 mg/dl), adequate liver function
(SGOT and bilirubin < 1.5 times ULN), and adequate renal function (creatinine < 1.5
mg/dL) before starting therapy. These tests must be performed within 14 days prior
to initial treatment.
- Patients must not have evidence of recent hemorrhage on baseline MRI of the brain,
with the following exceptions: presence of hemosiderin, resolving hemorrhage changes
related to surgery, presence of punctuate hemorrhage in the tumor.
- Patients must not have any significant medical illnesses that in the investigator's
opinion cannot be adequately controlled with appropriate therapy, would compromise
the patient's ability to tolerate this therapy or any disease that will obscure
toxicity or dangerously alter drug metabolism.
- Patients must not have proteinuria at screening as demonstrated by either
- Urine protein: creatinine (UPC) ratio ³ 1.0 at screening OR
- Urine dipstick for proteinuria ≥ 2+ (patients discovered to have ≥ 2+
proteinuria on dipstick urinalysis at baseline should undergo a 24 hour urine
collection and must demonstrate ≤ 1g of protein in 24 hours to be eligible).
- Patients must not have inadequately controlled hypertension (defined as systolic
blood pressure >150 and/or diastolic blood pressure > 100 mmHg) on antihypertensive
- Patients must not have any prior history of hypertensive crisis or hypertensive
- Patients must not have New York Heart Association Grade II or greater congestive
heart failure (see Appendix E).
- Patients must not have history of myocardial infarction or unstable angina within 12
months prior to study enrollment.