Re-irradiation With Fractionated Stereotactic Radiosurgery Plus Cetuximab in Patients With Recurrent Squamous Cell Carcinoma of the Head and Neck
Condition: Squamous Cell Carcinoma of the Head and Neck
MeSH terms: Carcinoma; Carcinoma, Squamous Cell; Squamous Cell Carcinoma of Head and Neck
Intervention: Cetuximab; Stereotactic radiosurgery
Intervention description: Cetuximab will be administered for 3 weekly doses commencing one week prior to stereotactic radiosurgery treatment as follows: * Cetuximab 400 mg / m2 day -7 (1 week prior to initiation of radiosurgery) * Cetuximab 250 mg/m2 days 0 and +8 (i.e. during the first and second week of fractionated stereotactic radiosurgery) Cetuximab will be administered at 400 mg/m2 IV over 120 minutes on day -7 (loading dose) and 250 mg/m2 IV on days 0 and 8 during the course of stereotactic radiosurgery.; Fractionated stereotactic radiosurgery, 8.0 Gy per fraction for 5 fractions (total: 40.0 Gy)
Intervention MeSH terms: Cetuximab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 48.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Fractionated Stereotactic Radiosurgery

Summary:

      This trial examines survival and toxicity in previously irradiated patients with squamous
      cell carcinoma of the head and neck (SCCHN) treated with radiosurgery and cetuximab and to
      evaluate the acute and late toxicities associated with the above therapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically proven recurrent squamous cell carcinoma of the head and neck (SCCHN),
             who has received prior radiotherapy with or without chemotherapy. New primary is
             allowed if location is in a previously irradiated field. Biopsy is recommended for
             each recurrence; but is not mandated per study. This will be at the discretion of the
             principal investigator.

          -  Prior radiation dose of at least 60 Gy.

          -  Disease confined to locoregional site and can be encompassed in a stereotactic
             radiosurgery "portal"

          -  Tumor must be deemed to be inoperable or unresectable either by clinical or
             radiographic criteria. These criteria include encasement of great vessels, vertebral
             invasion or undue peri-operative risk.

          -  Prior surgery for recurrent or new SCCHN is allowed in previously irradiated patients.
             A minimum of 4 weeks should elapse between any surgery and treatment on study.
             However, high risk pathologic features should be present, such as positive margins,
             positive lymphadenopathy, perineural or angiolymphatic invasion. Measurable disease
             must be present for assessment of response.

          -  Karnofsky performance status > 60 (ECOG 0-2)

          -  Prior treatment with an EGFR Inhibitor is allowed if it was a part of prior curative
             therapy and was completed at least 30 days prior to commencement of study therapy

          -  Any number of prior chemotherapy regimens are allowed

          -  Measurable disease on imaging studies (MRI, CT, PET-CT or physical exam)

          -  Age > 18

          -  Estimated life expectancy > 12 weeks

          -  No prior radiation therapy or chemotherapy within 1 month of study enrollment

          -  No prior chemotherapy or targeted therapy within the previous 4 weeks

          -  ANC > 1000, PLT>75,000, Serum creatinine<2.5 mg/dL, Bilirubin <1.5 x upper limits of
             normal (ULN)

          -  Diabetes must be controlled prior to PET-CT scanning (blood glucose <200 mg/dL)

          -  Ability to provide written informed consent

        Exclusion Criteria:

          -  Evidence of distant metastasis on upright chest x-ray (CXR), computed tomography (CT)
             or other staging studies

          -  History of any cancer other than SCCHN (except non-melanoma skin cancer or carcinoma
             in situ of the cervix) within the last 5 years.

          -  Patients in their reproductive age group should use an effective method of birth
             control. Patients who are breast-feeding, or have a positive pregnancy test will be
             excluded from the study

          -  Any co-morbidity or condition of sufficient severity to limit full compliance with the
             protocol per assessment by the investigator

          -  Concurrent serious infection

          -  History of known hypersensitivity to cetuximab or similar agents