Intraoperative Placement of Cesium-131 Permanent Interstitial Brachytherapy in Head and Neck Cancer

Primary Objective:

To assess the effect of Cesium 131 brachytherapy in subjects with resectable recurrent cancer
of the head and neck by evaluating disease free survival (DFS) and comparing to a previous
cohort. Potential effects on locoregional control rate and overall survival will be explored.

Secondary Objective:

To assess toxicity associated with cesium 131 brachytherapy treatment.

Study Design Patients with a head and neck recurrent cancer who are planned to undergo
definitive tumor resection surgery that meet our inclusion and exclusion criteria will be
offered participation in this clinical trial.

Participant's Follow-up. The participant's medical records will be reviewed every 3 months
for 24 months to assess: loco-regional control, distant metastasis free survival, disease
free survival, and overall survival. This will allow us to assess the potential treatment
effect of cesium 131.

Inclusion Criteria:

- Subjects must have histologically or cytologically confirmed recurrent head and neck
cancer.

- Based on clinical and radiographic evidence the tumor needs to be deemed resectable
preoperatively by the surgeon and when necessary (determined by the surgeon) tumor
board review.

- Patients must have potentially curable disease

- Karnofsky Performance status ≥ 60% (ECOG/Zubrod 0,1,or 2)

- Subjects must have normal organ and marrow function as defined below:

- Hemoglobin ≥ 7.0 g/dl

- Absolute neutrophil count (ANC) > 500/mcL

- Platelet count ≥ 75,000/mcL

- Patients with recurrent/previous treated head and neck squamous cell carcinoma that is
deemed surgically resectable by the treating physician but at high risk for recurrence
due to concerns regarding close and/or margins due to locations on or near critical
structures such as internal or common carotid, skull base, deep cervical musculature,
and other areas that may limit the possibility of an enbloc resection. This group
otherwise would be considered for retreatment with radiation and/or chemoradiation.

- Subjects must have the ability to understand and the willingness to sign a written
informed consent document.

Exclusion Criteria:

- Patients deemed to have un-resectable disease by the treating surgeon or upon tumor
board review.

- Patients with exposed carotid artery preoperatively requiring sacrifice or bypass
intra-operatively

- Patients with active pharyngocutaneous fistula

- Patients may have had a recent previous hospital admission (within 30 days) or be
admitted preoperatively but not for the following conditions

- Unstable angina

- Congestive heart failure

- Severe hypothyroidism TSH >10

---- Endocrine consult and intervention may allow participation at the
discretion of the principal investigator for a thyroid-stimulating hormone
(TSH) > 10.

- Patients deemed to be "High Risk" by pre admission testing (CPM) or by a
preoperative risk assessment by the hospitalist for perioperative
complications

- Subjects with more than one site of distant metastatic disease (beyond the
head and neck) as evidenced by computerized tomography (CT) scan or positron
emission tomography/CT (PET/CT) or biopsy ---- A subject with a single lung
nodule (deemed cancerous by PET/CT or Biopsy) will not be excluded.

- Subjects receiving any other investigational agents.

- Subjects with untreated brain metastases/central nervous system disease will be
excluded from this clinical trial because of their poor prognosis and because they
often develop progressive neurologic dysfunction that would confound the evaluation of
neurologic and other adverse events.

- History of allergic reactions attributed to compounds of similar chemical or biologic
composition to Cesium 131 or other agents used in this study.

- Pregnant or breastfeeding women are excluded from this study because Cesium 131 has
the potential for teratogenic or abortifacient effects. Because there is an unknown,
but potential risk for adverse events in nursing infants secondary to treatment of the
mother with Cesium 131, breastfeeding should be discontinued if the mother is treated
with Cesium 131. These potential risks may also apply to other agents used in this
study.

- Subjects who are HIV-positive will be excluded from the study. HIV-positive patients
on combination antiretroviral therapy are ineligible because of the potential for
pharmacokinetic interactions with Cesium 131. In addition, these subjects are at
increased risk of lethal infections when treated with marrow suppressive therapy.
Appropriate studies will be undertaken in patients receiving combination
antiretroviral therapy when indicated.