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A Trial of the Effects of Intravenous GC4419 on the Incidence and Duration of Severe Oral Mucositis (OM) in Patients Receiving Post-Operative or Definitive Therapy with Single-Agent Cisplatin plus IMRT for Locally Advanced, Non-Metastatic Squamous Cell Carcinoma of the Oral Cavity or Oropharynx

Study Summary

  • As part of this study, the patient will receive a new treatment aimed at reducing the risk of oral mucositis (OM). OM is a common side effect of patients receiving radiation and/or chemotherapy to the oral cavity. OM is the breakdown of tissue in the mouth leading to open sores and debilitating pain. At any time in treatment, patients receiving this particular treatment have around a 66{1f271575cd6051458901182c7c4c4f48bdfabd4170eb34ee1127140158f2ee5c} chance of developing severe OM (WHO Grade 3-4). (Source: http://www.ncbi.nlm.nih.gov/pubmed/17398022)
  • Patients will come in daily to receive study drug through IV, then receive radiation. Once a week, patients will receive chemotherapy. The treatment will last for 7 weeks.
  • The goal this new treatment is to not only reduce overall incidence of OM in these patients but also to reduce the overall time that a patient would be suffering from OM and also delay the initial onset of OM.
  • This trial is double-blinded, which means we will not know if you receive the treatment or a placebo.  The chances of receiving treatment are 2:1.
  • About 200 people will take part in this research study

Protocol

  • GT-201

Phase

  • II

Investigator

  • Dr. Waqas Rehman

Disease

  • Squamous Cell Carcinoma of Oral Cavity or Oropharynx

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Inclusion

  • Pathology confirming squamous cell carcinoma of head and neck (may also be called oral cavity or oropharynx)
  • 18 or older
  • Able to carry out most daily tasks by yourself (ECOG≤2)
  • Be receiving combined weekly chemotherapy and daily radiation for treatment

Exclusion

  • Tumor of lips, larynx, hypopharynx, nasopharynx, sinuses or salivary glands
  • Metastatic disease, also called Stage IV
  • Prior radiation to the area of cancer
  • Prior chemotherapy
  • Participation in another clinical trial within last 30 days
  • Already on a significantly modified diet (i.e. liquids only and/or inability to feed orally)
  • Active infectious disease. History of HIV or active Hepatitis B or C
  • Female patients that are breastfeeding
  • Requirement to be treated with nitrates while on study

NOTE: The inclusion and exclusion criteria for this study may be confusing, so if you are having a hard time deciding if you may be eligible, feel free to contact us!


If you have any questions regarding this study or think that
you or your loved one may be eligible, please feel free to contact:

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