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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Phase II Trial of Super Selective Intra-arterial Repeated Infusion of Cetuximab (Erbitux) With Reirradiation for Treatment of Relapsed/Refractory Glioblastoma Multiforme, Anaplastic Astrocytoma, and <

Brief Summary: 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.

Detailed Summary:
Sponsor: Northwell Health

Current Primary Outcome:

  • Progression Free Survival (PFS) [ Time Frame: 6 months ]
    The 6-month PFS will be estimated by calculating the proportion of patients who are alive at 6 months from treatment commencement and are progression-free.
  • Overall Survival (OS) [ Time Frame: 2 years ]
    OS will be calculated as the time from treatment initiation to the date of death.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Composite overall response rate (CORR) through the Response Evaluation Criteria In Solid Tumors (RECIST) [ Time Frame: 6 months ]
    Subjects will be classified according to the RECIST criteria, which is a composite of MRI changes, clinical response and changes in steroid use.
  • Toxicities graded according to the NCI Common Toxicity Criteria (CTCAE) version 4.03 [ Time Frame: 6 months ]
    Toxicities will be tabulated and graded according to the NCI Common Toxicity Criteria (CTCAE) version 4.03


Original Secondary Outcome: Same as current

Information By: Northwell Health

Dates:
Date Received: May 27, 2016
Date Started: May 2016
Date Completion: May 2021
Last Updated: January 27, 2017
Last Verified: January 2017