A Study of Experimental Individualized Chemotherapy Treatment for Nasopharyngeal Cancer Based on Epstein Barr Virus DNA

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"Volunteer for research at UC Davis and contribute to discoveries that may improve health care for you, your family, and your community!"
Age: 18 years or older
Gender:
Any
Healthy Volunteers: No
Keywords: Epstein Barr Virus, EBV, Nasopharyngeal Carcinoma, head and neck cancer
Type: Drug study, Phase 2/3
Target:
21 Participants
Investigator:
Description
You are being asked to take part in this study because you have nasopharyngeal cancer (in the head and neck region of your body). Your cancer has not spread to other parts of your body. People who are not in a study are usually treated with radiation and chemotherapy, followed by more chemotherapy. There are several FDA-approved chemotherapy drugs that are commonly used as part of this treatment. For patients who receive the usual approach for this cancer, on average 70 patients out of 100 are free of cancer at five years.

This study is being done to see how people with your type of cancer respond to different chemotherapies, based on a specific viral marker in their blood. This viral marker is called the Epstein Barr virus, (EBV). A more individualized approach to treating your type of cancer might be found using this blood marker.
This study requires

The study team will make sure you qualify to take part in the study. Qualified participants will receive detailed information about the study. This may include a list of study-related tests and procedures.

Who can participate

Inclusion criteria:

  • Biopsy proven (from primary lesion and/or lymph nodes) diagnosis of cancer of the nasopharynx
  • Patients must have detectable pretreatment plasma EBV DNA, determined by the central lab prior to Step 2 registration
  • Stage II-IVB disease (American Joint Committee on Cancer [AJCC], 7th edition [ed.]) with no evidence of distant metastasis, based upon the following minimum diagnostic workup:
  • History/physical examination by a Medical Oncologist or Clinical Oncologist or Radiation Oncologist or Ear, Nose, Throat specialist (ENT), which must include an endoscopic evaluation, a complete list of current medications, and assessment of weight and weight loss in the past 6 months within 21 days prior to registration
  • Evaluation of tumor extent with magnetic resonance imaging (MRI) of the nasopharynx and neck within 28 days prior to registration; if MRI is medically contraindicated, obtain computed tomography (CT) scan with =< 3 mm contiguous slices with contrast and bone windows (to evaluate base of skull involvement); Note: If a treatment planning CT scan is used, it must be with =< 3 mm contiguous slices with contrast and be read by a radiologist
  • To rule out distant metastasis, patients must undergo the following imaging within 28 days prior to registration:
  • A CT scan with contrast of the chest, abdomen, and/or pelvis or a total body positron emission tomography (PET)/CT scan (non-contrast PET/CT is acceptable)
  • A bone scan only when there is suspicion of bone metastases (a PET/CT scan can substitute for the bone scan)
  • Zubrod performance status 0-1 within 21 days prior to registration
  • Absolute neutrophil count (ANC) >= 1,500 cells/mm^3
  • Platelets >= 100,000 cells/mm^3
  • Hemoglobin >= 8.0 g/dl (Note: the use of transfusion or other intervention to achieve hemoglobin [Hgb] >= 8.0 g/dl is acceptable)
  • Total bilirubin =< 1.5 x institutional upper limit of normal (ULN)
  • Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) =< 1.5 x institutional ULN
  • Alkaline phosphatase =< 1.5 x institutional ULN
  • Serum creatinine =< 1.5 mg/dl or calculated creatinine clearance (CC) >= 50 ml/min determined by 24-hour urine collection or estimated by Cockcroft-Gault formula
  • Negative serum pregnancy test within 14 days prior to registration for women of childbearing potential
  • Women of childbearing potential and male participants who are sexually active must agree to use a medically effective means of birth control throughout protocol treatment
  • Patient must provide study specific informed consent prior to study entry, including the mandatory pre-treatment plasma EBV DNA assay

Exclusion criteria:

  • Prior invasive malignancy (except node negative, non-melanomatous skin cancer) unless disease free for a minimum of 1095 days (3 years) (for example, carcinoma in situ of the breast, oral cavity, or cervix are all permissible)
  • Prior systemic chemotherapy for the study cancer; note that prior chemotherapy for a different cancer is allowable; however, at least 6-weeks recovery is necessary if the last regimen included nitrosourea or mitomycin
  • Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields
  • Patients with hearing loss assessed to be primarily sensorineural in nature, requiring a hearing aid, or intervention (i.e. interfering in a clinically significant way with activities of daily living); a conductive hearing loss from tumor-related otitis media is allowed
  • = Grade 2 peripheral sensory neuropathy (CTCAE, v. 4.0)

  • Severe, active co-morbidity, defined as follows:
  • Major medical or psychiatric illness, which in the investigator's opinion would interfere with the completion of therapy and follow up or with full understanding of the risks and potential complications of the therapy
  • Unstable angina and/or uncontrolled congestive heart failure
  • Myocardial infarction within the last 6 months
  • Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration; note that patients switched from IV antibiotics and currently on oral antibiotics whose infection is assessed to be adequately treated or controlled are eligible
  • Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within 30 days prior to registration
  • Acquired immune deficiency syndrome (AIDS) based upon current Centers for Disease Control and Prevention (CDC) definition; note, however, that human immunodeficiency virus (HIV) testing is not required for entry into this protocol
  • Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception
  • Prior allergic reaction to the study drug(s) involved in this protocol
  • Patients with undetectable pre-treatment plasma EBV DNA
Benefits and risks of participating
BENEFITS:

We cannot promise any benefits to you as a result of taking part in this research study.


RISKS:

The study doctor will discuss the risks associated with taking part in this research study.
Compensation
You will not be paid to take part in this research study.
Resources
Schedule
Study duration and period
All patients will receive radiation for 6 and a half weeks with weekly chemotherapy for about 6 weeks. Patients assigned to Groups 1, 2, and 3 will receive an additional 12 weeks of chemotherapy. Patients assigned to Group 4 will receive no additional chemotherapy. You will be seen in follow-up visits every 4 months for 2 years, every 6 months for 3 years, then once a year for your lifetime.
Recruitment period
From March 10, 2018
Location
UC Davis Comprehensive Cancer Center
4501 X Street
Sacramento, CA 95817
Research Topic
Conditions:
  • Epstein-Barr Virus Infection
  • Stage II Nasopharyngeal Carcinoma
  • Stage III Nasopharyngeal Carcinoma
  • Stage IVA Nasopharyngeal Carcinoma
  • Stage IVB Nasopharyngeal Carcinoma

Have any questions or want to learn more? Leave your contact details below and the research team will reach out to you.


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