Clinical Trial Details
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NCT01939574 : A Explore Study of Bevacizumab Combined With Conventional Therapy in Glioblastoma
AgesMin: 18 Years Max: N/A
Inclusion Criteria:

- Histologically proven newly diagnosis of glioblastoma (WHO grade IV)

- The tumor must have a supratentorial component

- The patient must have recovered from the effects of surgery, postoperative infection,
and other complications before initial chemoradiation treatment

- Documentation of steroid doses within 14 days prior to initial chemoradiation

- Karnofsky performance status ? 70;

- Age ? 18

- Adequate renal function,hepatic function

- Systolic blood pressure ? 160 mg Hg or diastolic pressure ? 90 mg Hg within 14 days
prior to initial chemoradiation treatment

- Patient must provide study specific informed consent prior to study entry

- Women of childbearing potential and male participants must practice adequate

- For females of child-bearing potential, negative serum pregnancy test within 14 days
prior to initial chemoradiation treatment

Exclusion Criteria:

- Cancer-Related Exclusion Criteria

- Prior invasive malignancy (except for non-melanomatous skin cancer) unless
disease free for ?3 years

- Recurrent or multifocal malignant gliomas

- Metastases detected below the tentorium or beyond the cranial vault

- Prior chemotherapy or radiosensitizers for cancers of the head and neck region;
note that prior chemotherapy for a different cancer is allowable, except prior
temozolomide or bevacizumab. Prior use of Gliadel wafers or any other
intratumoral or intracavitary treatment are not permitted.

- Prior radiotherapy to the head or neck (except for T1 glottic cancer), resulting
in overlap of radiation fields

- Haematologic, Biochemical, Organ Function and other general exclusion criteria

- Unstable angina and/or congestive heart failure within the last 6 months

- Transmural myocardial infarction within the last 6 months

- Evidence of recent myocardial infarction or ischemia by the findings of S-T
elevations of ? 2mm using the analysis of an EKG performed within 14 days of
initial chemoradiation treatment

- New York Heart Association grade II or greater congestive heart failure
requiring hospitalization within 12 months prior to initial chemoradiation

- History of stroke, cerebral vascular accident (CVA) or transient ischemic attack
within 6 months

- Serious and inadequately controlled cardiac arrhythmia

- Acute bacterial or fungal infection requiring intravenous antibiotics at the
time of registration

- Chronic obstructive pulmonary disease exacerbation or other respiratory illness
requiring hospitalization or precluding study therapy at the time of initial
chemoradiation treatment

- Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects;
note, however,that laboratory tests for liver function and coagulation
parameters are not required for entry into this protocol

- Inability to undergo MRI (e.g., due to safety reasons,such as presence of a
pacemaker) or PET

- Contradiction to Bevacizumab treatment
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