Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Genentech, Inc.
Information provided by (Responsible Party):
Northwestern University
ClinicalTrials.gov Identifier:
NCT00536952
First received: September 27, 2007
Last updated: June 25, 2013
Last verified: June 2013

September 27, 2007
June 25, 2013
February 2008
October 2014   (final data collection date for primary outcome measure)
  • 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 ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • Patient comfort and/or disturbance during radiotherapy treatment as assessed daily by Radiation Treatment Disturbance Disturbance Measures questionnaire [ Time Frame: Daily during radiation treatment ] [ Designated as safety issue: No ]
  • Treatment-related symptoms as assessed daily by the Head and Neck Symptom Inventory Scale (MD Anderson Symptom Inventory)
  • Quality of life as assessed weekly by the Functional Assessment of Cancer Therapy - Head & Neck questionnaire
  • Patient comfort and/or disturbance during radiotherapy treatment as assessed daily by the Radiation Treatment Disturbance Measures questionnaire
Complete list of historical versions of study NCT00536952 on ClinicalTrials.gov Archive Site
  • Reduction in amount of thick oropharyngeal secretions associated with cancer therapy. [ Time Frame: At baseline, prior to radiation and study treatment, and after radiation. ] [ Designated as safety issue: No ]
  • Incidence of mucositis, infections, and aspiration pneumonia [ Time Frame: Weekly during study treatment. ] [ Designated as safety issue: Yes ]
  • Incidence of ≥ grade 2 mucositis as assessed weekly by CTCAE
  • Salivary DNA levels
  • Incidence of bacterial and fungal infections as assessed weekly by clinical exam
  • Incidence of aspiration pneumonia as assessed weekly by clinical and radiographic exam
  • Tumor control and survival rate for 2 years
Not Provided
Not Provided
 
Pilot Study of Pulmozyme (rhDNase) in Patients With Head and Neck Cancers Treated With Radiation Therapy + Chemotherapy
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.

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.

Interventional
Phase 0
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Supportive Care
Head and Neck Cancer
  • Drug: Pulmozyme
    Pulmozyme 2.5 mL ampules (2.5 mg) will be nebulized and inhaled once daily using a recommended nebulizer
    Other Name: dornase alfa inhalation solution
  • Drug: Placebo
    Placebo 2.5 mL ampules (2.5 mg) will be nebulized and inhaled once daily using a recommended nebulizer
  • Radiation: Radiation Therapy
    5 days per week for 4 weeks
  • Experimental: Arm 1
    Pulmozyme
    Interventions:
    • Drug: Pulmozyme
    • Radiation: Radiation Therapy
  • Placebo Comparator: Arm 2
    Placebo
    Interventions:
    • Drug: Placebo
    • Radiation: Radiation Therapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
36
December 2016
October 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00536952
NU 06N2, STU00001045, GENENTECH-NU-06N2
Yes
Northwestern University
Northwestern University
Genentech, Inc.
Study Chair: Bharat B. Mittal, MD Robert H. Lurie Cancer Center
Northwestern University
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP