Super-selective Intra-arterial Repeated Infusion of Cetuximab for the Treatment of Newly Diagnosed Glioblastoma
| Status: | Recruiting |
|---|---|
| Conditions: | Cancer, Brain Cancer, Brain Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/17/2018 |
| Start Date: | June 2016 |
| End Date: | June 2019 |
| Contact: | John Boockvar, MD |
| Email: | jboockvar@northwell.edu |
| Phone: | 212-434-4836 |
Phase I/II Trial of Super-selective Intra-arterial Repeated Infusion of Cetuximab for the Treatment of Newly Diagnosed Glioblastoma
Primary brain cancer kills up to 10,000 Americans a year. These brain tumors are typically
treated by surgery, radiation therapy and chemotherapy, either individually or in
combination. Present therapies are inadequate, as evidenced by the low 5-year survival rate
for brain cancer patients, with median survival at approximately 12 months. Glioma is the
most common form of primary brain cancer, afflicting approximately 7,000 patients in the
United States each year. These highly malignant cancers remain a significant unmet clinical
need in oncology. GBM often has a high expression EFGR (Epidermal Growth Factor Receptor)
which is blocked by Cetuximab (CTX). The investigators have recently completed a separate
Phase I clinical trial using superselective intra-arterial cerebral infusion (SIACI) of CTX
after blood brain barrier disruption (BBBD) for recurrent GBM (Chakraborty et al, in
revision, Journal of Neurooncology). The investigators found that intra-arterial infusion of
CTX is well tolerated with few adverse effects. The investigators hypothesize that in
patients with newly diagnosed GBM, repeated SIACI of this drug after BBBD will be safe and
efficacious for our patients when combined with standard chemoradiation (STUPP protocol).
This trial will be a non-randomized open label Phase I/II clinical trial. In addition to
standard chemotherapy and radiation therapy (STUPP protocol) the patient will be given CTX
intra-arterially after BBBD for a total of three doses at approximately post surgery days 30,
120 and 210.
treated by surgery, radiation therapy and chemotherapy, either individually or in
combination. Present therapies are inadequate, as evidenced by the low 5-year survival rate
for brain cancer patients, with median survival at approximately 12 months. Glioma is the
most common form of primary brain cancer, afflicting approximately 7,000 patients in the
United States each year. These highly malignant cancers remain a significant unmet clinical
need in oncology. GBM often has a high expression EFGR (Epidermal Growth Factor Receptor)
which is blocked by Cetuximab (CTX). The investigators have recently completed a separate
Phase I clinical trial using superselective intra-arterial cerebral infusion (SIACI) of CTX
after blood brain barrier disruption (BBBD) for recurrent GBM (Chakraborty et al, in
revision, Journal of Neurooncology). The investigators found that intra-arterial infusion of
CTX is well tolerated with few adverse effects. The investigators hypothesize that in
patients with newly diagnosed GBM, repeated SIACI of this drug after BBBD will be safe and
efficacious for our patients when combined with standard chemoradiation (STUPP protocol).
This trial will be a non-randomized open label Phase I/II clinical trial. In addition to
standard chemotherapy and radiation therapy (STUPP protocol) the patient will be given CTX
intra-arterially after BBBD for a total of three doses at approximately post surgery days 30,
120 and 210.
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
protocol.
- 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
We found this trial at
1
site
New York, New York 10065
Principal Investigator: John Boockvar, MD
Phone: 212-434-3900
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