Super-selective Intra-arterial Repeated Infusion of Cetuximab for the Treatment of Newly Diagnosed Glioblastoma

Part of paid clinical trials in New York, New York.

Sponsor
Northwell Health
Study ID
NCT02861898
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Intra-arterial Cetuximab — DRUG
  • Intra-arterial Mannitol — DRUG

Study Details

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.

Key Dates

Start date
Jun 30, 2016
Status verified
May 2026
Primary completion
Dec 31, 2028
Completion
Dec 31, 2029

Study Design

Enrollment
33 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Intra-arterial Cetuximab after BBBD
    Mannitol 20% 12.5ml over two minutes for Blood Brain Barrier (BBB) disruption followed by CTX administered intra-arterially for three doses at a dose of 250mg/m2

Primary Outcome Measure

Progression Free Survival (PFS) [ Time Frame: 6 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Lenox Hill Brain Tumor CenterNew YorkNew York10075
John Boockvar, MD
[email protected]
212-434-3900
Tamika Wong, MPH
[email protected]
212-434-4836
John Boockvar, MD (PRINCIPAL_INVESTIGATOR)
David Langer, MD (SUB_INVESTIGATOR)
Rafael Ortiz, MD (SUB_INVESTIGATOR)
Jed Pollack, MD (SUB_INVESTIGATOR)
Anuj Goenka, MD (SUB_INVESTIGATOR)
Christopher Filippi, MD (SUB_INVESTIGATOR)
Sherese Fralin, NP (SUB_INVESTIGATOR)
Ashley Ray, NP (SUB_INVESTIGATOR)
Tamika Wong, MPH (SUB_INVESTIGATOR)
Karissa Tan, NP (SUB_INVESTIGATOR)
Shamik Chakraborty, MD (SUB_INVESTIGATOR)

Find similar trials in New York, NY

By condition
Brain cancer
By specialty
OncologyNeuro-oncology
By research site
Lenox Hill Brain Tumor Center· New York, NY

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