Clinical Trial Details
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NCT01738646 : Ph II SAHA and Bevacizumab for Recurrent Malignant Glioma Patients
PhasePhase 2
AgesMin: 18 Years Max: N/A
Inclusion Criteria:

- Age > 18 years.

- An interval of at least 4 weeks between prior surgical resection or one week from
stereotactic biopsy.

- An interval of at least 12 weeks from the end of prior radiotherapy unless there is a
new area of enhancement consistent with recurrent tumor outside of the radiation
field, or there is biopsy-proven tumor progression

- An interval of at least 4 weeks from prior chemotherapy [6 weeks for nitrosoureas, 1
week for daily administered chemotherapy (metronomic dosing)] or investigational
agent unless the patient has recovered from all anticipated toxicities associated
with that therapy.

- Eastern Cooperative Oncology Group (ECOG) 0-1.

- Hematocrit ? 29%, hemoglobin ? 9, absolute neutrophil ?1,500 cells/microliter,
platelets ? 100,000 cells/microliters.

- Serum creatinine, serum glutamic oxaloacetic transaminase(SGOT) and bilirubin < 1.5
times upper limit of normal.

- Signed informed consent approved by the Institutional Review Board prior to patient

- No evidence of hemorrhage on the baseline MRI or CT scan other than those that are
stable grade 1.

- If sexually active, patients will take contraceptive measures for the duration of the
treatments. Medically acceptable contraceptives include: (1) surgical sterilization
(such as a tubal ligation, hysterectomy, vasectomy), (2) approved hormonal
contraceptives (such as birth control pills, patches, implants or injections), (3)
barrier methods (such as a condom or diaphragm) used with a spermicide, or (4) an
intrauterine device (IUD).

Exclusion Criteria:

Disease-specific exclusions

- More than 2 prior episodes of disease progression

- Prior therapy with histone deacetylase inhibitors; valproic acid is not permitted and
patients previously treated with valproic acid must be off valproic acid for at least
30 days prior to initiation of study medication

- Prior bevacizumab therapy

- Co-medication that may interfere with study results; e.g. immuno-suppressive agents
other than corticosteroids

- Active infection requiring intravenous antibiotics

- Severe hepatic insufficiency, active viral hepatitis or HIV infection

- Requires therapeutic anti-coagulation with warfarin

General medical exclusions

Subjects meeting the following criteria are ineligible for study entry:

- Inability to comply with study and/or follow-up procedures

Bevacizumab-specific exclusions

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

- Any prior history of hypertensive crisis or hypertensive encephalopathy

- New York Heart Association (NYHA) Grade II or greater congestive heart failure (see
Appendix E)

- History of myocardial infarction or unstable angina within 6 months prior to study

- History of stroke or transient ischemic attack within 6 months prior to study

- Significant vascular disease (e.g., aortic aneurysm, aortic dissection)

- Symptomatic peripheral vascular disease

- Evidence of bleeding diathesis or coagulopathy

- Major surgical procedure, open biopsy, or significant traumatic injury within 28 days
prior to study enrollment 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 study enrollment

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

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

- Proteinuria at screening as demonstrated by either:

- Urine protein:creatinine (UPC) ratio >= 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).

- Known hypersensitivity to any component of bevacizumab

- Pregnant (positive pregnancy test) or lactating. Refuse the use of effective means of
contraception (men and women) in subjects of child-bearing potential
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