Clinical Trial Details
Braintumor Website

[Information provided by:, which provides patients, family members, and members of the public easy and free access to information on clinical studies for a wide range of diseases and conditions.]

NCT02861898 : Super-selective Intra-arterial Repeated Infusion of Cetuximab for the Treatment of Newly Diagnosed Glioblastoma
PhasePhase 1/Phase 2
AgesMin: 18 Years Max: N/A
Inclusion Criteria:

- Male or female patients of =18 years of age.

- Patients with a documented histologic diagnosis of newly diagnosed glioblastoma
multiforme (GBM)

- Patients with pathology confirmed histologic EGFR overexpression

- Patients must have at least one confirmed and evaluable tumor site.*

*A confirmed tumor site is one in which is biopsy-proven. NOTE: Radiographic
procedures (e.g., Gd-enhanced MRI or CT scans) documenting existing lesions must have
been performed within two weeks of treatment on this research study.

- Patients must have a Karnofsky performance status =70% (or the equivalent ECOG level
of 0-2) and an expected survival of = three months.

- No chemotherapy for two weeks prior to treatment under this research protocol and no
external beam radiation for eight weeks prior to treatment under this research

- Patients must have adequate hematologic reserve with WBC=3000/mm3, absolute
neutrophils =1500/mm3 and platelets =100,000/ mm3. Patients who are on Coumadin must
have a platelet count of =150,000/ mm3

- Pre-enrollment chemistry parameters must show: bilirubin<1.5X the institutional upper
limit of normal (IUNL); AST or ALT<2.5X IUNL and creatinine<1.5X IUNL.

- Pre-enrollment coagulation parameters (PT and PTT) must be =1.5X the IUNL.

- Patients must agree to use a medically effective method of contraception during and
for a period of three months after the treatment period. A pregnancy test will be
performed on each premenopausal female of childbearing potential immediately prior to
entry into the research study.

- Patients must be able to understand and give written informed consent. Informed
consent must be obtained at the time of patient screening.

Exclusion Criteria:

- Women who are pregnant or lactating.

- Women of childbearing potential and fertile men will be informed as to the potential
risk of conception while participating in this research trial and will be advised that
they must use effective contraception during and for a period of three months after
the treatment period.

- Patients with significant intercurrent medical or psychiatric conditions that would
place them at increased risk or affect their ability to receive or comply with
treatment or post-treatment clinical monitoring

- Patients with radiological evidence of leptomeningeal disease.

- Patients with history of allergic reaction to CTX

- Patients who initiated or completed chemo/RT
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