Study to Assess Safety and Tolerability of AG013 in Oral Mucositis in Subjects Receiving Induction Chemotherapy for the Treatment of Cancers of the Head and Neck

Not Recruiting

Trial ID: NCT00938080


The purpose of this study is to assess the safety and tolerability of AG013 (genetically modified L. lactis bacteria engineered to secrete human Trefoil Factor 1), and to explore the ability of AG013 to attenuate the course and severity of oral mucositis (OM) in subjects receiving induction chemotherapy for the treatment of head and neck cancer.

Official Title

A Phase 1b, Multi-center, Single Blinded, Placebo-controlled, Sequential Dose Escalation Study to Assess the Safety and Tolerability of Topically Applied AG013 in Subjects Receiving Induction Chemotherapy for the Treatment of Cancers of the Head and Neck

Stanford Investigator(s)

A. Dimitrios Colevas, MD
A. Dimitrios Colevas, MD

Professor of Medicine (Oncology) and, by courtesy, of Otolaryngology - Head & Neck Surgery (OHNS) and of Radiation Oncology (Radiation Therapy)

Quynh-Thu Le, MD
Quynh-Thu Le, MD

Katharine Dexter McCormick and Stanley McCormick Memorial Professor and Professor, by courtesy, of Otolaryngology - Head & Neck Surgery (OHNS)


Inclusion Criteria:

   - Willing and able to understand and sign the study specific Informed Consent Form (ICF)
   approved by the site's Institutional Review Board

   - Males or females 18 years or older

   - Recently diagnosed with pathologically-confirmed squamous cell carcinoma of the head
   and neck (e.g., oral cavity, oropharynx, hypopharynx, larynx, nasopharynx, lips,
   sinuses, salivary glands, unknown primary)

   - Planned to receive at least two cycles of induction chemotherapy of the same regimen
   consisting of cisplatin/fluorouracil (PF) or cisplatin/fluorouracil/docetaxel (PFT).
   The planned CT cycles must be of the same length and must be a minimum of 14 days in

   - Karnofsky performance score ≥ 60%

   - Screening laboratory assessments:

   - Hemoglobin ≥ 10g/dl

   - White blood count ≥ 3500 cells/mm3

   - Absolute neutrophil counts ≥ 1500 cells/ mm3

   - Direct bilirubin ≤ 2x upper limit of normal (ULN)

   - Serum AST and ALT ≤ 3 x ULN

   - Serum creatinine ≤ 2 mg/dl

   - Serum pregnancy test: negative for females of childbearing potential: A women is
   considered to be of child bearing potential unless she has had a tubal ligation or is
   postmenopausal (without a menstrual period for at least one year)

   - Subjects of childbearing potential must agree to utilize effective contraceptive
   methods of birth control during study participation and for 30 days following the last
   treatment with IMP

   - Have documented mouth pain during CT Cycle 1 (i.e., OMDQ question 2 score of ≥ 2
   during CT Cycle 1)

Exclusion Criteria:

   - Prior radiation to the head and neck

   - Chemotherapy within 21 days prior to study start

   - Presence of active infectious disease excluding oral candidiasis

   - Current use of antibiotic rinses or troches

   - Alcohol abuse syndrome; recovered alcoholics may be included

   - Presence of OM (WHO Grade > 0)

   - Chronic immunosuppression

   - Known seropositive for HIV or hepatitis B or C

   - Use of investigational agent within 30 days of signing informed consent

   - Teeth extractions within 7 days prior to the start of CT administration

   - Female subjects who are pregnant or nursing

   - Known sensitivity to any investigational agent

   - Inability to give informed consent or comply with study requirements

   - Unwilling or unable to complete subject diary

   - Any other clinical condition, psychiatric condition or prior therapy that, in the
   opinion of the Investigator, would make the subject unsuitable for the study or unable
   or to comply with follow-up visits


biological: AG013

other: Placebo

other: Placebo

other: Placebo

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Cancer Clinical Trials Office

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