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|NCT01903330 : ERC1671/GM-CSF/Cyclophosphamide for the Treatment of Glioblastoma Multiforme|
|Ages||Min: 18 Years Max: N/A|
- Patients must have histologically confirmed diagnosis of a recurrent/progressive WHO
grade IV malignant gliomas (glioblastoma multiforme and gliosarcoma) and meet the
following inclusion criteria:
- Age =18 years of age.
- Histologic diagnosis of glioblastoma or gliosarcoma (WHO Grade IV).
- Karnofsky performance status (KPS) of = 70%.
- Life expectancy > 12 weeks.
- First or second relapse of glioblastoma.
- Previous treatment for glioblastoma must include surgery (biopsy, partial resection,
or full surgical resection), conventional radiation therapy and temozolomide (TMZ).
- MRI record must be obtained showing the MRI was conducted at least 4 weeks after any
salvage surgery, and at least 12 weeks after radiation therapy, or at least 4 weeks
after radiation for a new lesion outside the prior primary radiation field.
- If prior therapy with gamma knife or other focal high-dose radiation, must have
subsequent histologic documentation of local relapse, or relapse with new lesion
outside the irradiated field.
- Resolution of all chemotherapy or radiation-related toxicities = CTCAE Grade 1
severity, except for alopecia and hematologic toxicity. Patients taking temozolomide
can start study treatment 23 days from the last temozolamide dose. For all other
chemotherapy drugs, study treatment can start as long as adverse events related to
their treatment is = to Grade 1.
- Systemic corticosteroid therapy must be at a dose of = 4 mg of dexamethasone or
equivalent per day during the week prior to Day 1.
- Patients must have normal organ and marrow function as defined below:
- hemoglobin (Hbg) > 9g/dL,
- leukocytes >1,500/microliter (mcL)
- absolute neutrophil count>1,000/mcL
- CD4 count > 450/mcL
- total bilirubin within normal institutional limits
- aspartate aminotransferase (AST)(SGOT)/ Alanine aminotransferase(ALT)(SGPT)<2.5 X
institutional upper limit of normal
- serum creatinine < 1.5 mg/dl
- Signed informed consent approved by the Institutional Review Board;
- If sexually active, patients must agree to take contraceptive measures for the
duration of the treatments.
- Subjects unable to undergo an MRI with contrast.
- Presence of diffuse leptomeningeal disease
- History, presence, or suspicion of metastatic disease
- Administration of immunosuppressive drugs less than 2 weeks prior to first dose of
ERC1671, except dexamethasone for cerebral edema as detailed above;
- Prior receipt of bevacizumab or other VEGF- or VEGF receptor-targeted agents
- Known contraindication or hypersensitivity to any component of bevacizumab.
- Evidence of recent hemorrhage on screening MRI of the brain with the following
exceptions: presence of hemosiderin; resolving hemorrhagic changes related to surgery;
presence of punctate hemorrhage in the tumor.
- Significant vascular disease (e.g., aortic aneurysm, aortic dissection) or recent
peripheral arterial thrombosis within 6 months prior to Day 1.
- Evidence of bleeding diathesis or coagulopathy as documented by an elevated PT, PTT or
- History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess
within 6 months prior to Day 1.
- Urine protein: creatinine ratio = 1.0 at screening;
- Anticipation of need for major surgical procedure during the course of the study.
- Serious non-healing wound, ulcer, or bone fracture.
- Active infection requiring treatment, known immunosuppressive disease, active systemic
autoimmune diseases such as lupus, receipt of systemic immunosuppressive therapy,
human immunodeficiency virus (HIV) infection, Hepatitis B or Hepatitis C Uncontrolled
hypertension, blood pressure of > 150 mmHg systolic and > 100 mmHg diastolic, or
history of hypertensive encephalopathy. Subjects with any known uncontrolled
inter-current illness including ongoing or active infection, symptomatic congestive
heart failure (NYHA Gr.2 or >), myocardial infarction, unstable angina pectoris,
within the past 12 months
- Stroke, transient ischemic attack, unstable angina, myocardial infarction or
congestive heart failure (New York Heart Association Grade II or greater) within the
past 12 months. Unstable or severe inter-current medical conditions chronic renal
disease, or uncontrolled diabetes mellitus.
- Women who are pregnant or lactating. All female patients with reproductive potential
must have a negative pregnancy test prior to Day 1.
- Men refusing to exercise a reliable form of contraception.
- History of any malignancy (other than glioblastoma) during the last three years except
non-melanoma skin cancer, in situ cervical cancer, treated superficial bladder cancer
or cured, early-stage prostate cancer in a patient with Prostate Surface Antigen (PSA)
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