Phase
Condition
Carcinoma
Brain Tumor
Gliomas
Treatment
N/AClinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
No evidence of bleeding diathesis or coagulopathy
Fertile patients must use effective contraception during and for >= 2 months after completion of study therapy
No diarrhea >= grade 1
Histologically confirmed primary brain neoplasm, meningioma, or head and neck cancer [WHO grade 2 or 3 disease--no WHO grade 4 primary brain neoplasms (i.e., glioblastoma or gliosarcoma)]
Patients with head and neck cancer must not have any of the following:
Evidence of metastatic disease
Evidence of tumor invasion to major vessels (e.g., the carotid)
History of bleeding related to tumor or radiotherapy during or after completion of radiotherapy
Must have undergone cranial irradiation
Must have radiographic evidence to support the diagnosis of radiation necrosis and/or surgical biopsy evidence of necrosis without tumor within the past 2 months
Must have evidence of progressive neurologic signs or symptoms appropriate to the location of the radiation necrosis
No abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 28 days
No significant traumatic injury within the past 28 days
No evidence of active CNS hemorrhage
Karnofsky performance status 60-100%
No clinically significant cardiovascular disease, including any of the following:
Inadequately controlled hypertension (i.e., systolic BP > 140 mm Hg and/or diastolic BP > 90 mm Hg despite antihypertensive medication)
Large vessel cerebrovascular accident within the past 6 months
Myocardial infarction or unstable angina within the past 6 months
No clinically significant cardiovascular disease, including any of the following:
NYHA class II-IV congestive heart failure
Serious or inadequately controlled cardiac arrhythmia
Significant vascular disease (e.g., aortic aneurysm or history of aortic dissection)
Clinically significant peripheral vascular disease
At least 6 months since prior radiotherapy
Platelet count > 75,000/mm^3
Granulocyte count > 1,500/mm^3
Creatinine < 1.0 times ULN
AST < 2.5 times ULN
Not pregnant or nursing
Negative pregnancy test
Prior chemotherapy for tumor allowed
Prior tyrosine kinase inhibitors of VEGF receptor (VEGFR) allowed
More than 28 days since prior and no concurrent major surgical procedure or open biopsy
Concurrent dexamethasone allowed provided patient is on a stable dose for >= 1 week prior to study entry
Concurrent full-dose anticoagulants (e.g., warfarin) with PT INR > 1.5 allowed provided the following criteria are met:
In-range INR (usually between 2 and 3) and patient is on a stable dose of oral anticoagulant for 1 week or on a stable dose of low molecular weight heparin
No active bleeding or pathological condition that carries a high risk of bleeding
Concurrent full-dose anticoagulants (e.g., warfarin) with PT INR > 1.5 allowed provided the following criteria are met: No evidence of serious or nonhealing wound, ulcer, or bone fracture
No concurrent chemotherapy or tyrosine kinase inhibitors of VEGFR
No prior bevacizumab
More than 7 days since prior core biopsy
History of seizures allowed provided the patient is receiving anticonvulsant therapy
Hemoglobin >= 9.0 g/dL
Bilirubin =< 1.5 times upper limit of normal (ULN)
No other concurrent investigational agents
Study Design
Study Description
Connect with a study center
M D Anderson Cancer Center
Houston, Texas 77030
United StatesSite Not Available

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