Amifostine With IMRT for Submandibular and Sublingual Salivary Sparing During Head and Neck Cancer Treatment

This study has been terminated.
(Study terminated by Principal Investigator; no patients completed study.)
Sponsor:
Collaborator:
MedImmune LLC
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00409331
First received: December 7, 2006
Last updated: July 31, 2012
Last verified: July 2012
  Purpose

Primary Objective:

To determine if amifostine in combination with IMRT can mitigate the decrease in production of saliva by the submandibular and sublingual salivary glands in patients with HNSCC.

Secondary Objectives:

  1. To establish a parotid gland dose volume histogram (DVH) versus measured flow relationship in this patient population:

    • When the mean dose is < 24-26 Gy (shift recovery time to left)
    • When the mean dose is > 24-26 Gy (DVH shift)
  2. To observe mucositis in the following lower dose RT areas:

    • Upper lip
    • Lower lip
    • Right cheek
    • Left cheek
    • Right ventral and lateral tongue
    • Left ventral and lateral tongue
    • Floor of the mouth
    • Soft palate
    • Hard palate.
  3. To observe the incidence and patterns of occipital scalp epilation;
  4. To observe the incidence of dysphagia using the List Performance Status Scale (LPSS); and
  5. To further evaluate the safety profile of amifostine in this patient population.

Condition Intervention Phase
Head and Neck Cancer
Drug: Amifostine
Procedure: Intensity- Modulated Radiation Therapy
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study To Assess The Efficacy of Amifostine for Submandibular and Sublingual Salivary Sparing During Head and Neck Cancer Treatment With Intensity- Modulated Radiation Therapy (IMRT) for Parotid Salivary Sparing

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • 12-month Clinically Relevant Salivary Flow (CRSF) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Primary endpoint is bilateral, 12-month Clinically Relevant Salivary Flow (CRSF) by the submandibular and sublingual salivary glands, collectively. Saliva production will be quantified using selective quantitative submandibular sialometry (total collection time of 5 minutes). A CRSF is equivalent to production of 0.05 mL of saliva post-radiation in a 5-minute collection period.


Enrollment: 3
Study Start Date: December 2006
Study Completion Date: January 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: IMRT + Amifostine
Intensity-Modulated Radiation Therapy (IMRT) 2.0 to 2.2 Gy delivered in 30 fractions + Amifostine 500 mg, 2 divided doses subcutaneously 30-60 minutes prior to IMRT.
Drug: Amifostine
500 mg in two divided doses subcutaneously given 30-60 minutes prior to IMRT.
Other Name: Ethyol
Procedure: Intensity- Modulated Radiation Therapy
2.0 to 2.2 Gy delivered in 30 fractions
Other Name: IMRT

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Adult men and women of at least 18 years of age at the time of patient entry;
  2. Women of reproductive potential (defined as being <1 year post-menopausal) must have a negative serum pregnancy test within 7 days of study entry;
  3. Men and women of reproductive potential must agree to practice an effective method of avoiding pregnancy (including oral or implanted contraceptives, intrauterine device (IUD), female condom, diaphragm with spermicide, cervical cap, use of a condom by the sexual partner or sterile sexual partner) beginning at the time the informed consent is signed, and must agree to continue using such precautions while receiving IMRT through 6 weeks after the last dose of amifostine or RT, whichever is the last therapy discontinued;
  4. Patients undergoing definitive or post-operative IMRT as follows:
  5. Definitive Patients: Histology confirmed unknown primary T0N1-2bM0 or oropharynx Stage I, II, III, IV (TX, T1-T2, favorable T3 (exophytic) N0-N2b, M0), small volume primary and nodal, not requiring chemotherapy during RT (i.e., induction chemo is acceptable as well as concurrent biological therapy e.g., Cetuximab), squamous cell carcinoma (AJCC Staging of HNSCC). Lymph nodes bilaterally of the neck are at risk for metastatic disease and require irradiation per clinical judgment.
  6. Post-operative Patients: Histology confirmed oral cavity, oropharynx, larynx and hypopharynx squamous cell carcinoma (AJCC Staging of HNSCC): *Stage III and IV squamous cell carcinoma treated with surgery as the primary modality requiring post-operative RT, but not receiving concurrent chemotherapy. *Indications for post-operative RT include: unfavorable T3 and T4 primaries, compromised margins, nodal metastases, extracapsular nodal extension, perineural invasion and lymphovascular invasion.
  7. Zubrod performance status of 0 or 1
  8. Adequate nutritional status as determined by the treating physician in conjunction with consultation with clinical nutritionists, as indicated.
  9. Hemoglobin must be greater than or equal to 10 g/dL.
  10. At least one parotid should keep a mean RT dose of < 24-26 Gy. If this cannot be achieved on one side, then the contralateral parotid dosing goal is to keep the mean dose as low as possible, typically <15 Gy.
  11. It is anticipated that at least one submandibular gland will receive a mean dose >24-26 Gy.
  12. Written informed consent and HIPAA authorization obtained from the patient prior to receipt of any study medication or beginning study procedures.

Exclusion Criteria:

  1. Evidence of significant wound infection, fistula, or major wound dehiscence at time of patient entry.
  2. Carcinomas of the paranasal sinuses, nasopharynx, or N3 at time of patient entry.
  3. Presence of prior malignancies <5 years other than non-melanoma skin cancer or cervical, breast or bladder cancer in situ.
  4. T3N0 glottic cancer at time of patient entry.
  5. Prior chemotherapy for other cancer within less than or equal to 3 years prior to patient entry.
  6. Planned concurrent or adjuvant chemotherapy.
  7. Less than gross total resection for patients on post-operative RT.
  8. Prior head neck irradiation except for localized non-melanomatous cutaneous carcinomas.
  9. Salivary gland disease, e.g. Sjogren's disease at time of patient entry.
  10. Pregnant or nursing at the time of patient entry or positive serum pregnancy test within 7 days of study entry.
  11. Use of pilocarpine or cevimeline during participation in the study.
  12. General medical or psychological conditions that might preclude the patient from completion of the study or from understanding and signing the informed consent.
  13. Evidence of distant metastases.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00409331

Locations
United States, Texas
U.T. M.D. Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
MedImmune LLC
Investigators
Principal Investigator: Mark Chambers, MD M.D. Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00409331     History of Changes
Other Study ID Numbers: 2006-0234
Study First Received: December 7, 2006
Results First Received: December 11, 2009
Last Updated: July 31, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by M.D. Anderson Cancer Center:
Head and Neck Cancer
HNSCC
Submandibular and Sublingual Salivary Sparing
Amifostine
Ethyol
Radiation Therapy

Additional relevant MeSH terms:
Head and Neck Neoplasms
Neoplasms by Site
Neoplasms
Amifostine
Radiation-Protective Agents
Protective Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 23, 2014