<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01728480</url>
  </required_header>
  <id_info>
    <org_study_id>I 209611</org_study_id>
    <secondary_id>NCI-2012-02140</secondary_id>
    <nct_id>NCT01728480</nct_id>
  </id_info>
  <brief_title>Entolimod in Treating Patients With Stage III-IV Squamous Cell Head and Neck Cancer Receiving Cisplatin and Radiation Therapy</brief_title>
  <official_title>A Phase I Study of CBLB502 in the Treatment of Patients With Poor Prognosis Advanced Squamous Cell Carcinomas of the Head and Neck Receiving Chemoradiotherapy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Roswell Park Cancer Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Cancer Institute (NCI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
    <collaborator>
      <agency>Cleveland BioLabs, Inc.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Roswell Park Cancer Institute</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This phase I trial studies the side effects and best dose of entolimod in treating patients&#xD;
      with stage III-IV or recurrent head and neck cancer. Biological therapies, such as entolimod,&#xD;
      may stimulate the immune system in different ways and stop tumor cells from growing.&#xD;
      Entolimod may also prevent side effects caused by chemotherapy with cisplatin and radiation&#xD;
      therapy. Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in&#xD;
      chemotherapy, such as cisplatin, work in different ways to stop the growth of cancer cells,&#xD;
      either by killing the cells or by stopping them from dividing. Giving entolimod together with&#xD;
      cisplatin and radiation therapy may kill more tumor cells&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      PRIMARY OBJECTIVES:&#xD;
&#xD;
      I. To define the Phase II dose of CBLB502 (entolimod) when given as weekly injections during&#xD;
      irradiation with cisplatin, for patients with poor prognosis advanced squamous cell&#xD;
      carcinomas of the head and neck receiving chemoradiotherapy.&#xD;
&#xD;
      SECONDARY OBJECTIVES:&#xD;
&#xD;
      I. To describe the adverse event (AE) profile and the dose limiting toxicities of CBLB502&#xD;
      when administered weekly in combination with cisplatin and radiation therapy.&#xD;
&#xD;
      II. To determine the maximally tolerated dose (if observed) of CBLB502 in combination with&#xD;
      cisplatin and radiation therapy.&#xD;
&#xD;
      III. To describe the pharmacokinetics (PK) of CBLB502 when administered in combination with&#xD;
      cisplatin.&#xD;
&#xD;
      IV. To describe the pharmacodynamics (PD) of CBLC502 by examining plasma levels of various&#xD;
      cytokines, including filgrastim (granulocyte-colony stimulating factor [G-CSF]), interleukin&#xD;
      (IL)-6, IL-8, IL-10, and tumor necrosis factor-alpha (TNF-α).&#xD;
&#xD;
      V. To describe any clinical activity of CBLB502 in the form of mitigation of mucositis.&#xD;
&#xD;
      VI. To describe the response rate to chemoradiotherapy in combination with CBLB502.&#xD;
&#xD;
      OUTLINE: This is a dose-escalation study of entolimod.&#xD;
&#xD;
      Patients undergo intensity-modulated radiation therapy (IMRT) 5 times per week for 7 weeks,&#xD;
      receive cisplatin intravenously (IV) once weekly for 7 weeks, and entolimod subcutaneously&#xD;
      (SC) on days 1, 8, 15, 22, 29, 36, and 43.&#xD;
&#xD;
      After completion of study treatment, patients are followed up for 3 months.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Financial Sponsor requested termination&#xD;
  </why_stopped>
  <start_date>January 2014</start_date>
  <primary_completion_date type="Anticipated">October 2015</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Adverse events defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related graded according to Common Toxicity Criteria for Adverse Events (CTCAE) version 4.0</measure>
    <time_frame>Up to 3 months after completion of study treatment</time_frame>
    <description>Summarized descriptively by time point (mean, standard deviation). All safety analyses will be presented by dose cohort and overall as well as examined for relation to demographic parameters (i.e., gender, weight, body surface area [BSA]) and covariance or dependence on PK, PD, or presence of anti-entolimod antibodies at baseline and/or the development of entolimod antibodies.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>PK of entolimod when administered in combination with cisplatin and radiation therapy</measure>
    <time_frame>Predose, and at 2, 4, 6, 8, and 12 (+/- 2) hours postdose on Day 1</time_frame>
    <description>A population PK model will be developed utilizing the PK time points collected and used to estimate individual areas under the curve (AUCs) or clearance (CL) of entolimod. The effect of patient factors, such as demographics and ECOG status, on entolimod PK will be evaluated by the model to help explain the interpatient variability in PK. Entolimod AUC, as well as the observed Crnax, will then be tested for association changes in cytokine levels, such as G-CSF, IL-6, IL-8, IL- 10 and TNF-alpha.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The percentage of patients with mucositis, measured using the World Health Organization (WHO) mucositis global severity score and the oral mucositis daily questionnaire (OMDQ)</measure>
    <time_frame>Up to 3 months after completion of study treatment</time_frame>
    <description>The percentage of patients with mucositis will be tabulated overall and by dose level.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Mucositis</condition>
  <condition>Recurrent Squamous Cell Carcinoma of the Hypopharynx</condition>
  <condition>Recurrent Squamous Cell Carcinoma of the Larynx</condition>
  <condition>Recurrent Squamous Cell Carcinoma of the Lip and Oral Cavity</condition>
  <condition>Recurrent Squamous Cell Carcinoma of the Nasopharynx</condition>
  <condition>Recurrent Squamous Cell Carcinoma of the Oropharynx</condition>
  <condition>Recurrent Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity</condition>
  <condition>Recurrent Verrucous Carcinoma of the Larynx</condition>
  <condition>Recurrent Verrucous Carcinoma of the Oral Cavity</condition>
  <condition>Stage III Squamous Cell Carcinoma of the Hypopharynx</condition>
  <condition>Stage III Squamous Cell Carcinoma of the Larynx</condition>
  <condition>Stage III Squamous Cell Carcinoma of the Lip and Oral Cavity</condition>
  <condition>Stage III Squamous Cell Carcinoma of the Nasopharynx</condition>
  <condition>Stage III Squamous Cell Carcinoma of the Oropharynx</condition>
  <condition>Stage III Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity</condition>
  <condition>Stage III Verrucous Carcinoma of the Larynx</condition>
  <condition>Stage III Verrucous Carcinoma of the Oral Cavity</condition>
  <condition>Stage IV Squamous Cell Carcinoma of the Hypopharynx</condition>
  <condition>Stage IV Squamous Cell Carcinoma of the Nasopharynx</condition>
  <condition>Stage IVA Squamous Cell Carcinoma of the Larynx</condition>
  <condition>Stage IVA Squamous Cell Carcinoma of the Lip and Oral Cavity</condition>
  <condition>Stage IVA Squamous Cell Carcinoma of the Oropharynx</condition>
  <condition>Stage IVA Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity</condition>
  <condition>Stage IVA Verrucous Carcinoma of the Larynx</condition>
  <condition>Stage IVA Verrucous Carcinoma of the Oral Cavity</condition>
  <condition>Stage IVB Squamous Cell Carcinoma of the Larynx</condition>
  <condition>Stage IVB Squamous Cell Carcinoma of the Lip and Oral Cavity</condition>
  <condition>Stage IVB Squamous Cell Carcinoma of the Oropharynx</condition>
  <condition>Stage IVB Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity</condition>
  <condition>Stage IVB Verrucous Carcinoma of the Larynx</condition>
  <condition>Stage IVB Verrucous Carcinoma of the Oral Cavity</condition>
  <condition>Stage IVC Squamous Cell Carcinoma of the Larynx</condition>
  <condition>Stage IVC Squamous Cell Carcinoma of the Lip and Oral Cavity</condition>
  <condition>Stage IVC Squamous Cell Carcinoma of the Oropharynx</condition>
  <condition>Stage IVC Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity</condition>
  <condition>Stage IVC Verrucous Carcinoma of the Larynx</condition>
  <condition>Stage IVC Verrucous Carcinoma of the Oral Cavity</condition>
  <condition>Tongue Cancer</condition>
  <arm_group>
    <arm_group_label>Treatment (entolimod, IMRT, cisplatin)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients undergo IMRT 5 times per week for 7 weeks, receive cisplatin IV once weekly for 7 weeks, and entolimod SC on days 1, 8, 15, 22, 29, 36, and 43.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>entolimod</intervention_name>
    <description>Given SC</description>
    <arm_group_label>Treatment (entolimod, IMRT, cisplatin)</arm_group_label>
    <other_name>CBLB502</other_name>
    <other_name>TLR5 agonist CBLB502</other_name>
    <other_name>toll-like receptor 5 agonist CBLB502</other_name>
  </intervention>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>intensity-modulated radiation therapy</intervention_name>
    <description>Undergo IMRT</description>
    <arm_group_label>Treatment (entolimod, IMRT, cisplatin)</arm_group_label>
    <other_name>IMRT</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>cisplatin</intervention_name>
    <description>Given IV</description>
    <arm_group_label>Treatment (entolimod, IMRT, cisplatin)</arm_group_label>
    <other_name>CACP</other_name>
    <other_name>CDDP</other_name>
    <other_name>CPDD</other_name>
    <other_name>DDP</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>pharmacological study</intervention_name>
    <description>Correlative studies</description>
    <arm_group_label>Treatment (entolimod, IMRT, cisplatin)</arm_group_label>
    <other_name>pharmacological studies</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>laboratory biomarker analysis</intervention_name>
    <description>Correlative studies</description>
    <arm_group_label>Treatment (entolimod, IMRT, cisplatin)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Histologically proven diagnosis of squamous cell carcinoma (stage III - IV) of the&#xD;
             nasopharynx, oropharynx, oral cavity, paranasal sinuses, larynx, hypopharynx; the&#xD;
             tumor must be human papillomavirus (HPV) negative or the patient should have a greater&#xD;
             than 10 packs year smoking history; OR need for post-operative concurrent&#xD;
             chemoradiotherapy (extracapsular extension, positive surgical margin, more than 1&#xD;
             lymph node positive, stage III - IV disease, perineural invasion, vascular tumor&#xD;
             embolus) for histologically proven squamous cell carcinoma of the paranasal sinuses,&#xD;
             nasopharynx, larynx, hypopharynx, with extension to structures of the oropharynx&#xD;
&#xD;
          -  Have an Eastern Cooperative Oncology Group (ECOG) performance status of =&lt; 2&#xD;
&#xD;
          -  Induction chemotherapy (up to 3 cycles of cetuximab/taxanes/platinum based regimens)&#xD;
             is allowed&#xD;
&#xD;
          -  Patients or their legal representatives must be able to comprehend and provide written&#xD;
             informed consent&#xD;
&#xD;
          -  Absolute neutrophil count =&gt; 1,500/uL&#xD;
&#xD;
          -  Platelets &gt;= 100,000/uL&#xD;
&#xD;
          -  Total bilirubin within normal institutional limits&#xD;
&#xD;
          -  Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase&#xD;
             [SGOT])/alanine aminotransferase (ALT)(serum glutamate pyruvate transaminase [SGPT])&#xD;
             =&lt; 2.5 x institutional upper limit normal (ULN)&#xD;
&#xD;
          -  Calculated creatinine clearance &gt;= 60 mL/min (Cockcroft-Gault equation)&#xD;
&#xD;
          -  12-Lead Electrocardiogram (ECG) with normal tracing or non-clinically significant&#xD;
             changes that do not require medical intervention&#xD;
&#xD;
          -  Bazett's corrected QT (QTcB) interval &lt; 470 msec at any timepoint prior to receiving&#xD;
             the first dose of study drug (mean of replicate values, correction per institutional&#xD;
             standard) and no history of Torsades des Pointes or other symptomatic QTcB abnormality&#xD;
&#xD;
          -  Absence of orthostatic hypotension&#xD;
&#xD;
          -  Patients must be sufficiently recovered from induction chemotherapy to allow&#xD;
             initiation therapy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Women of childbearing potential who do not have a negative serum pregnancy test&#xD;
             performed within 7 days prior to the start of study drug&#xD;
&#xD;
          -  Male and female patients of child-bearing potential who do not agree to use&#xD;
             double-barrier contraceptive measures, oral contraception, or avoidance of intercourse&#xD;
             during the study and for 90 days after last investigational drug dose received&#xD;
&#xD;
          -  Contraindication to full course chemoradiotherapy with cisplatin&#xD;
&#xD;
          -  Previous treatment with a toll-like receptor 5 (TLR5) agonist&#xD;
&#xD;
          -  Presence of neutralizing antibodies to CBLB502&#xD;
&#xD;
          -  Patients with an active infection or with a fever &gt;= 38.5ºC within 3 days of the first&#xD;
             scheduled day of dosing; patients who are registered but develop a fever of &gt;= 38.5ºC&#xD;
             may remain in the study if the fever abates prior to the expiration of the screening&#xD;
             procedures; if the screening procedures have expired, the patient may be re-screened&#xD;
             once afebrile&#xD;
&#xD;
          -  Patients with a history of significant cardiovascular, neurological, endocrine,&#xD;
             gastrointestinal, respiratory or inflammatory illness that could preclude their&#xD;
             participation in the study, pose an undue medical hazard or interfere with the&#xD;
             interpretation of the study results, including, but not limited to, patients with&#xD;
             congestive heart failure (New York Heart Association [NYHA] class 3 or class 4);&#xD;
             unstable angina; cardiac arrhythmia; recent (within the preceding 6 months) myocardial&#xD;
             infarction or stroke; hypertension requiring &gt; 2 medications for adequate control;&#xD;
             diabetes mellitus with &gt; 2 episodes of ketoacidosis in the preceding 12 months;&#xD;
             chronic obstructive pulmonary disease (COPD) requiring &gt; 2 hospitalizations in the&#xD;
             preceding 12 months&#xD;
&#xD;
          -  Patients with a history of, or known autoimmune disease, but not limited to systemic&#xD;
             lupus erythematosus, rheumatoid arthritis, systemic sclerosis, ankylosing spondylitis,&#xD;
             sarcoidosis, vasculitis, Wegener's granulomatosis, Hashimoto's thyroiditis, ulcerative&#xD;
             colitis, Crohn's disease, Goodpasture's disease, multiple sclerosis, etc.&#xD;
&#xD;
          -  Patients with any other medical, psychiatric or social condition that would preclude&#xD;
             their participation in the study, pose an undue medical hazard, interfere with the&#xD;
             conduct of the study or interfere with interpretation of the study results&#xD;
&#xD;
          -  Patients taking sucralfate, palifermin or amifostine&#xD;
&#xD;
          -  Patients receiving hematopoietic growth factors&#xD;
&#xD;
          -  Patients currently taking, or who have taken within 30 days of the initiation of&#xD;
             protocol therapy, any immunomodulatory therapy, including pharmacologic doses of&#xD;
             glucocorticoids (topical and inhalation glucocorticoids are permitted), azathioprine,&#xD;
             methotrexate, interferon-alpha, interferon-beta, interluekin-2, etanercept,&#xD;
             infliximab, tacrolimus, cyclosporine, mycophenolic acid, etc&#xD;
&#xD;
          -  Patients with a history of hypersensitivity reactions to any of the components of&#xD;
             CBLB502 or cisplatin&#xD;
&#xD;
          -  Women who are pregnant or lactating or who are planning on becoming pregnant during&#xD;
             the study or for 90 days after completion of the study&#xD;
&#xD;
          -  Patients who have received an investigational therapy within 4 weeks of signing the&#xD;
             informed consent for the current study&#xD;
&#xD;
          -  Patients with a history of, patients who were treated for, or patients who are&#xD;
             suspected of having, hepatitis B, and hepatitis C or human immunodeficiency virus&#xD;
             (HIV); patients suspected of having any of these conditions should undergo appropriate&#xD;
             evaluations prior to being enrolled in the study&#xD;
&#xD;
          -  Surgery with significant defect or flap in the oral cavity&#xD;
&#xD;
          -  Poor dentition or ill-fitting dental appliances (can be enrolled if this can be&#xD;
             corrected by a dentist prior to start of radiation therapy)&#xD;
&#xD;
          -  Presence of other medical conditions causing mucositis (e.g., rheumatologic,&#xD;
             gastroesophageal reflux, etc.)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Anurag Singh</last_name>
    <role>Principal Investigator</role>
    <affiliation>Roswell Park Cancer Institute</affiliation>
  </overall_official>
  <removed_countries>
    <country>United States</country>
  </removed_countries>
  <verification_date>December 2013</verification_date>
  <study_first_submitted>November 13, 2012</study_first_submitted>
  <study_first_submitted_qc>November 13, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 19, 2012</study_first_posted>
  <last_update_submitted>December 10, 2013</last_update_submitted>
  <last_update_submitted_qc>December 10, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 11, 2013</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Carcinoma</mesh_term>
    <mesh_term>Carcinoma, Squamous Cell</mesh_term>
    <mesh_term>Laryngeal Neoplasms</mesh_term>
    <mesh_term>Oropharyngeal Neoplasms</mesh_term>
    <mesh_term>Carcinoma, Verrucous</mesh_term>
    <mesh_term>Squamous Cell Carcinoma of Head and Neck</mesh_term>
    <mesh_term>Nasopharyngeal Carcinoma</mesh_term>
    <mesh_term>Paranasal Sinus Neoplasms</mesh_term>
    <mesh_term>Tongue Neoplasms</mesh_term>
    <mesh_term>Mucositis</mesh_term>
    <mesh_term>Laryngeal Diseases</mesh_term>
    <mesh_term>Recurrence</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cisplatin</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01728480
org study id: I 209611
secondary id: NCI-2012-02140
nct id: NCT01728480
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
This phase I trial studies the side effects and best dose of entolimod in treating patients
      with stage III-IV or recurrent head and neck cancer. Biological therapies, such as entolimod,
      may stimulate the immune system in different ways and stop tumor cells from growing.
      Entolimod may also prevent side effects caused by chemotherapy with cisplatin and radiation
      therapy. Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in
      chemotherapy, such as cisplatin, work in different ways to stop the growth of cancer cells,
      either by killing the cells or by stopping them from dividing. Giving entolimod together with
      cisplatin and radiation therapy may kill more tumor cells
PRIMARY OBJECTIVES:

      I. To define the Phase II dose of CBLB502 (entolimod) when given as weekly injections during
      irradiation with cisplatin, for patients with poor prognosis advanced squamous cell
      carcinomas of the head and neck receiving chemoradiotherapy.

      SECONDARY OBJECTIVES:

      I. To describe the adverse event (AE) profile and the dose limiting toxicities of CBLB502
      when administered weekly in combination with cisplatin and radiation therapy.

      II. To determine the maximally tolerated dose (if observed) of CBLB502 in combination with
      cisplatin and radiation therapy.

      III. To describe the pharmacokinetics (PK) of CBLB502 when administered in combination with
      cisplatin.

      IV. To describe the pharmacodynamics (PD) of CBLC502 by examining plasma levels of various
      cytokines, including filgrastim (granulocyte-colony stimulating factor [G-CSF]), interleukin
      (IL)-6, IL-8, IL-10, and tumor necrosis factor-alpha (TNF-α).

      V. To describe any clinical activity of CBLB502 in the form of mitigation of mucositis.

      VI. To describe the response rate to chemoradiotherapy in combination with CBLB502.

      OUTLINE: This is a dose-escalation study of entolimod.

      Patients undergo intensity-modulated radiation therapy (IMRT) 5 times per week for 7 weeks,
      receive cisplatin intravenously (IV) once weekly for 7 weeks, and entolimod subcutaneously
      (SC) on days 1, 8, 15, 22, 29, 36, and 43.

      After completion of study treatment, patients are followed up for 3 months.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Adverse events defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related graded according to Common Toxicity Criteria for Adverse Events (CTCAE) version 4.0
time frame: Up to 3 months after completion of study treatment
description: Summarized descriptively by time point (mean, standard deviation). All safety analyses will be presented by dose cohort and overall as well as examined for relation to demographic parameters (i.e., gender, weight, body surface area [BSA]) and covariance or dependence on PK, PD, or presence of anti-entolimod antibodies at baseline and/or the development of entolimod antibodies.
measure: PK of entolimod when administered in combination with cisplatin and radiation therapy
time frame: Predose, and at 2, 4, 6, 8, and 12 (+/- 2) hours postdose on Day 1
description: A population PK model will be developed utilizing the PK time points collected and used to estimate individual areas under the curve (AUCs) or clearance (CL) of entolimod. The effect of patient factors, such as demographics and ECOG status, on entolimod PK will be evaluated by the model to help explain the interpatient variability in PK. Entolimod AUC, as well as the observed Crnax, will then be tested for association changes in cytokine levels, such as G-CSF, IL-6, IL-8, IL- 10 and TNF-alpha.
measure: The percentage of patients with mucositis, measured using the World Health Organization (WHO) mucositis global severity score and the oral mucositis daily questionnaire (OMDQ)
time frame: Up to 3 months after completion of study treatment
description: The percentage of patients with mucositis will be tabulated overall and by dose level.
arm group label: Treatment (entolimod, IMRT, cisplatin)
arm group type: Experimental
description: Patients undergo IMRT 5 times per week for 7 weeks, receive cisplatin IV once weekly for 7 weeks, and entolimod SC on days 1, 8, 15, 22, 29, 36, and 43.
intervention type: Drug
intervention name: entolimod
description: Given SC
arm group label: Treatment (entolimod, IMRT, cisplatin)
other name: CBLB502
other name: TLR5 agonist CBLB502
other name: toll-like receptor 5 agonist CBLB502
intervention type: Radiation
intervention name: intensity-modulated radiation therapy
description: Undergo IMRT
arm group label: Treatment (entolimod, IMRT, cisplatin)
other name: IMRT
intervention type: Drug
intervention name: cisplatin
description: Given IV
arm group label: Treatment (entolimod, IMRT, cisplatin)
other name: CACP
other name: CDDP
other name: CPDD
other name: DDP
intervention type: Other
intervention name: pharmacological study
description: Correlative studies
arm group label: Treatment (entolimod, IMRT, cisplatin)
other name: pharmacological studies
intervention type: Other
intervention name: laboratory biomarker analysis
description: Correlative studies
arm group label: Treatment (entolimod, IMRT, cisplatin)
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Anurag Singh
role: Principal Investigator
affiliation: Roswell Park Cancer Institute
country: United States
responsible party type: Sponsor
mesh term: Carcinoma
mesh term: Carcinoma, Squamous Cell
mesh term: Laryngeal Neoplasms
mesh term: Oropharyngeal Neoplasms
mesh term: Carcinoma, Verrucous
mesh term: Squamous Cell Carcinoma of Head and Neck
mesh term: Nasopharyngeal Carcinoma
mesh term: Paranasal Sinus Neoplasms
mesh term: Tongue Neoplasms
mesh term: Mucositis
mesh term: Laryngeal Diseases
mesh term: Recurrence
mesh term: Cisplatin