Hypofractionated Stereotactic Radiotherapy With Bevacizumab in the Treatment of Recurrent Malignant Glioma

Status:Active, not recruiting
Conditions:Cancer, Brain Cancer
Therapuetic Areas:Oncology
Age Range:18 - Any
Start Date:July 2011
End Date:July 2019

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The best dose of radiation to be given with bevacizumab is currently unknown. This study will
use higher doses of radiation with bevacizumab than have been used before. This study will
test the safety of radiation given at different doses with bevacizumab to find out what
effects, good and/or bad, it has on the patient and the malignant glioma or related brain

Inclusion Criteria:

- Patients must have EITHER

- Histologically confirmed intracranial malignant glioma of the following types:
Glioblastoma, Anaplastic astrocytoma (AA), Anaplastic oligodendroglioma (AO),
Anaplastic oligo-astrocytoma (AOA) also called anaplastic mixed gliomas, Malignant
glioma NOS (not otherwise specified). Patients will be eligible if the original
histology was low-grade glioma and a subsequent histological diagnosis of a high grade
(malignant) glioma is made.


- Histologically confirmed low grade (WHO grade II) gliomas (such as low grade
astrocytoma, low grade oligodendroglioma, low grade oligo-astrocytoma (mixed gliomas),
or low grade glioma NOS) IF there is radiographic evidence by MRI of malignant
transformation but histologic confirmation of high grade (malignant) transformation
would not be otherwise undertaken for routine clinical care. Inclusion of patients in
this group will allow increased accrual rapidity by enrolling patients who are
otherwise ineligible for almost all malignant glioma trials yet whom are treated
presumptively for malignant glioma. The primary aim of the phase I study is not
determination of efficacy. Therefore, inclusion of such patients will not affect
efficacy analyses.

Participating site confirmation is adequate.

- Able to undergo brain MRI scans.

- MRI scan with gadolinium contrast showing geographically-circumscribed tumor ≤40 cc
incorporating both enhancing and non-enhancing volume. This is calculated by the
product of maximum measurements in 3 dimensions divided by 2. Tumors exceeding this
limit may be eligible and any question should be directed to a Radiation Oncology
Investigator and the MSK PI. (The MRI must be performed on a steroid dosage that has
been stable or decreasing for at least 5 days. Patients on no steroids are eligible.
If the steroid dose is increased between date of imaging and registration, a new
baseline MRI is required).

- Prior treatment with approximately 60 Gy of radiotherapy.

- Patients must have recovered from the toxic effects of prior therapy including but not
limited to:

- An interval of ≥ 4 weeks (28 days) from prior cytotoxic therapy except 6 weeks from

- An interval of ≥ 1 week (7 days) from any non-cytotoxic agents

- An interval of ≥ 3 months from the completion of radiation therapy

- Absolute neutrophil count ≥ 1,500/mm3.

- Platelet count ≥ 100,000/mm3.

- Hemoglobin ≥ 10 g/dl.

- Serum creatinine ≤ 2 times upper limit of normal.

- Total bilirubin ≤ 2 times upper limit of normal.

- SGOT and SGPT both ≤ 3 times upper limit of normal.

- ≥18 years of age.

- Karnofsky Performance Score ≥ 60

- Life expectancy ≥ 12 weeks

- Men and women with reproductive potential must agree to use an acceptable method of
birth control during treatment and for six months after completion of treatment.

- Written informed consent prior to registration on study.

Exclusion Criteria:

- Prior treatment with radiosurgery

- Prior disease progression/recurrence during or immediately following treatment with
bevacizumab. Any question should be directed to the PI.

- Multicentric glioma

- Other malignancy (with the exception of cervical carcinoma in situ or basal cell
carcinoma of the skin) for which there has been treatment within the last 3 years

- Serious medical or psychiatric illness that would in the opinion of the investigator
interferes with the prescribed treatment.

- Pregnant or breast feeding women

- Inadequately controlled hypertension (defined as systolic blood pressure >150 mmHg
and/or diastolic blood pressure > 100 mmHg)

- Any prior history of hypertensive crisis or hypertensive encephalopathy

- Grade 2 or greater congestive heart failure

- History of myocardial infarction, unstable angina, stroke, or transient ischemic
attack within 12 months prior to Day 1

- Significant vascular disease (e.g., aortic aneurysm, requiring surgical repair or
recent peripheral arterial thrombosis) within 6 months prior to Day 1

- History of hemoptysis ≥1/2 teaspoon of bright red blood per episode) within 1 month
prior to Day 1

- Evidence of bleeding diathesis or significant coagulopathy (in the absence of
therapeutic anticoagulation)

- Major surgical procedure, open biopsy, or significant traumatic injury within 28 days
prior to Day 1 of treatment or anticipation of need for major surgical procedure
during the course of the study

- Core biopsy or other minor surgical procedure, excluding placement of a vascular
access device, within 7 days prior to Day 1

- Serious, non-healing wound, active ulcer, or untreated bone fracture

- Proteinuria as demonstrated by a UPC ratio ≥ 1.0 at screening

- Known hypersensitivity to any component of bevacizumab

- History of peptic ulcer within the last 6 months

- Clinically significant peripheral vascular disease

- Craniotomy wound that has not sufficiently healed

- History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess
within 6 months prior to study enrollment

- Glioma showing prior spontaneous hemorrhage as determined from the clinical history or
from any preoperative CT or MRI scan (excluding grade 1 punctate, incidentally found).

- Longest uni-dimensional measurement of contrast enhancing tumor ≥ 4cm. Tumors
exceeding this limit may be eligible and any question should be directed to a
Radiation Oncology Investigator and the MSK PI.

- Tumor must not invade the corpus callosum

- Tumor must not invade the brainstem

- Suspected or documented radionecrosis
We found this trial at
Basking Ridge, New Jersey 07920
Basking Ridge, NJ
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Commack, New York 11725
Commack, NY
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500 Westchester Avenue
Harrison, New York 10604
Harrison, NY
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1275 York Ave
New York, New York 10021
(212) 639-2000
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
New York, NY
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San Francisco, California 94143
San Francisco, CA
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