Trial Information

A Pilot Study of Pulmozyme (rhDNase) in Patients With Head and Neck Cancers Treated With Radiation and Chemotherapy

OBJECTIVES:

- To determine if use of nebulized dornase alfa inhalation solution can improve the
overall daily symptom and quality of life as well as reduce treatment discomfort during
radiotherapy and chemotherapy in patients with stage III or IV squamous cell carcinoma
of the head and neck.

- To determine if once daily nebulized dornase alfa inhalation solution given prior to
radiotherapy can reduce thick oropharyngeal secretions associated with curative
radiotherapy and chemotherapy in these patients.

- To determine if reduction in thick oropharyngeal secretions with the use of nebulized
dornase alfa inhalation solution can decrease the incidence of mucositis, infections,
and aspiration pneumonia.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

- Arm I: Patients receive nebulized dornase alfa inhalation solution via oral inhalation
approximately 30 minutes prior to radiation therapy on days 1-5. Treatment continues
for up to 4 weeks (weeks 3-6 of radiation therapy) in the absence of disease
progression or unacceptable toxicity.

- Arm II: Patients receive nebulized placebo via oral inhalation approximately 30 minutes
prior to radiation therapy on days 1-5. Treatment continues for up to 4 weeks as in arm
I.

All patients are assessed for treatment-related symptoms and treatment disturbance daily
during radiation therapy. Patients are assessed for quality of life weekly during radiation
therapy and then monthly during follow-up for 3 months. Clinical symptoms (i.e., mucositis,
bacterial and fungal infections, and aspiration pneumonia) are also assessed weekly during
radiation therapy.

Sputum samples are collected prior to initiating radiation therapy (at baseline) and
periodically during week 3 of radiation treatment and evaluated for salivary DNA levels.

After completion of study therapy, patients are followed monthly for 3 months and then every
3-4 months for a minimum of 2 years.