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


Phase 0
18 Years
N/A
Open (Enrolling)
Both
Head and Neck Cancer

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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.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically or cytologically confirmed squamous cell carcinoma of the oral cavity,
nasopharynx, oropharynx, hypopharynx, or larynx

- Stage III or IV disease

- Confirmation from primary site and/or lymph nodes

- Patients with a history of head and neck cancer allowed provided they have not
received prior radiotherapy

- Prior localized radiotherapy for skin cancer arising in the head and neck region
is allowed

- Planning to receive radiation therapy and chemotherapy to the head and neck regions
with a minimum expected radiation dose of 60 Gy over 6 weeks

- Chemotherapy may include but is not limited to, cisplatin or carboplatin,
fluorouracil, hydroxyurea, docetaxel, and/or cetuximab

- Induction chemotherapy allowed

PATIENT CHARACTERISTICS:

- Karnofsky performance status 50-100%

- No prior allergic reaction or known sensitivity to dornase alfa inhalation solution

- No significant active infection or other severe complicating medical illness

- Not pregnant or nursing

- Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

- See Disease Characteristics

- No concurrent amifostine

- No mouth wash 1 hour before or after dornase alfa inhalation solution administration

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Supportive Care

Outcome Measure:

Treatment-related symptoms as assessed daily by the Head and Neck Symptom Inventory Scale (MD Anderson Symptom Inventory)

Outcome Time Frame:

5 times per week during study treatment and once per month up to 3 months post-treatment

Safety Issue:

No

Principal Investigator

Bharat B. Mittal, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Robert H. Lurie Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

NU 06N2

NCT ID:

NCT00536952

Start Date:

February 2008

Completion Date:

December 2016

Related Keywords:

  • Head and Neck Cancer
  • recurrent squamous cell carcinoma of the hypopharynx
  • stage III squamous cell carcinoma of the hypopharynx
  • stage IV squamous cell carcinoma of the hypopharynx
  • stage III squamous cell carcinoma of the larynx
  • stage IV squamous cell carcinoma of the larynx
  • recurrent squamous cell carcinoma of the larynx
  • recurrent squamous cell carcinoma of the lip and oral cavity
  • stage III squamous cell carcinoma of the lip and oral cavity
  • stage IV squamous cell carcinoma of the lip and oral cavity
  • recurrent squamous cell carcinoma of the nasopharynx
  • stage III squamous cell carcinoma of the nasopharynx
  • stage IV squamous cell carcinoma of the nasopharynx
  • recurrent squamous cell carcinoma of the oropharynx
  • stage III squamous cell carcinoma of the oropharynx
  • stage IV squamous cell carcinoma of the oropharynx
  • Head and Neck Neoplasms

Name

Location

Robert H. Lurie Comprehensive Cancer Center at Northwestern UniversityChicago, Illinois  60611