Super Selective Intra-arterial Repeated Infusion of Cetuximab (Erbitux) With Reirradiation for Treatment of Relapsed/Refractory GBM, AA, and AOA

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

Sponsor
Northwell Health
Study ID
NCT02800486
Phase
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
  • Hypofractionated re-irradiation — RADIATION

Study Details

Primary 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 of EFGR (Epidermal Growth Factor Receptor), which is associated with poor prognosis. Several methods of inhibiting this receptor have been tested, including monoclonal antibodies, vaccines, and tyrosine kinase inhibitors. The investigators hypothesize that in patients with recurring GBM, intracranial superselective intra-arterial infusion of Cetuximab (CTX), at a dose of 250mg/m2 in conjunction with hypofractionated radiation, will be safe and efficacious and prevent tumor progression in patients with recurrent, residual GBM.

Key Dates

Start date
May 31, 2016
Status verified
Apr 2026
Primary completion
May 31, 2035
Completion
May 31, 2036

Study Design

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

Arms

  • Experimental: Intra-arterial Cetuximab with Re-Irradiation
    Mannitol 20% 12.5ml over two minutes for blood brain barrier (BBB) disruption followed by Cetuximab administered intra-arterially for three doses at a dose of 250 mg/m2 combined with hypofractionated re-irradiation

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)
Alexis Demopoulos, MD (SUB_INVESTIGATOR)
Jed Pollack, MD (SUB_INVESTIGATOR)
Anuj Goenka, MD (SUB_INVESTIGATOR)
Sherese Fralin, NP (SUB_INVESTIGATOR)
Ashley Ray, NP (SUB_INVESTIGATOR)
Karissa Tan, NP (SUB_INVESTIGATOR)
Tamika Wong, MPH (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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