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

June 25, 2013 updated by: Northwestern University

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

RATIONALE: Nebulized dornase alfa inhalation solution may decrease the thickness of saliva in the mouth and improve quality of life in patients undergoing radiation therapy and chemotherapy for head and neck cancer. It is not yet known whether dornase alfa inhalation solution is more effective than a placebo in lessening the discomfort of treatment in these patients.

PURPOSE: This randomized clinical trial is studying how well dornase alfa inhalation solution works compared with a placebo in treating patients with stage III or stage IV head and neck cancer undergoing radiation therapy and chemotherapy.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Anticipated)

36

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60611-3013
        • Robert H. Lurie Comprehensive Cancer Center at Northwestern University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm 1
Pulmozyme
Drug: Pulmozyme
Pulmozyme 2.5 mL ampules (2.5 mg) will be nebulized and inhaled once daily using a recommended nebulizer
Other Names:
  • dornase alfa inhalation solution
Radiation: Radiation Therapy
5 days per week for 4 weeks
Placebo Comparator: Arm 2
Placebo
Radiation: Radiation Therapy
5 days per week for 4 weeks
Drug: Placebo
Placebo 2.5 mL ampules (2.5 mg) will be nebulized and inhaled once daily using a recommended nebulizer

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Treatment-related symptoms as assessed daily by the Head and Neck Symptom Inventory Scale (MD Anderson Symptom Inventory)
Time Frame: 5 times per week during study treatment and once per month up to 3 months post-treatment
5 times per week during study treatment and once per month up to 3 months post-treatment
Quality of life as assessed weekly by the Functional Assessment of Cancer Therapy - Head & Neck Neck questionnaire
Time Frame: Weekly during study treatment and once per month up to 3 months post-treatment.
Weekly during study treatment and once per month up to 3 months post-treatment.
Patient comfort and/or disturbance during radiotherapy treatment as assessed daily by Radiation Treatment Disturbance Disturbance Measures questionnaire
Time Frame: Daily during radiation treatment
Daily during radiation treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
Reduction in amount of thick oropharyngeal secretions associated with cancer therapy.
Time Frame: At baseline, prior to radiation and study treatment, and after radiation.
At baseline, prior to radiation and study treatment, and after radiation.
Incidence of mucositis, infections, and aspiration pneumonia
Time Frame: Weekly during study treatment.
Weekly during study treatment.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Northwestern University

Collaborators

Genentech, Inc.

Investigators

  • Study Chair: Bharat B. Mittal, MD, Robert H. Lurie Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2008

Primary Completion (Anticipated)

October 1, 2014

Study Completion (Anticipated)

December 1, 2016

Study Registration Dates

First Submitted

September 27, 2007

First Submitted That Met QC Criteria

September 27, 2007

First Posted (Estimate)

September 28, 2007

Study Record Updates

Last Update Posted (Estimate)

June 27, 2013

Last Update Submitted That Met QC Criteria

June 25, 2013

Last Verified

June 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NU 06N2
  • STU00001045 (Other Identifier: Northwestern University IRB)
  • GENENTECH-NU-06N2 (Other Grant/Funding Number: Genentech)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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