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Head and Neck Cancer

VTX-2337 for Recurrent or Metastatic Squamous Cell Carcinomas of the Head and Neck (7406)
Phase I Clinical Trial of VTX-2337, a small molecule Toll-Like Receptor 8 (TLR8) agonist in combination with cetuximab in patients with recurrent or metastatic squamous cell carcinomas of the head and neck (SCCHN)
Status Conditions Phase Study ID
Closed Head and Neck Cancer Phase I 7406
NCT01334177
Summary

This phase I trial studies the side effects and best dose of TLR8 Agonist VTX-2337 (VTX-2337) when given together with cetuximab in treating patients with locally advanced, recurrent, or metastatic squamous cell cancer of the head and neck (SCCHN). Biological therapies, such as VTX-2337 may stimulate the immune system in different ways and stop tumor cells from growing. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Giving VTX-2337 together with cetuximab may kill more tumor cells.


Investigator
Laura Chow
Location    
Seattle Cancer Care Alliance 800-804-8824  
Eligibility Criteria (must meet the following to participate in this study)
  • Patients with a histological or cytopathological confirmed diagnosis of squamous cell carcinoma of the head and neck region that is:
  • Locally advanced/recurrent and no longer amenable to local surgical or radiation therapy and/or
  • Has evidence of metastatic disease
  • Patients may have been previously treated with systemic therapy but are otherwise deemed currently platinum-refractory, or would be deemed inappropriate or intolerant to platinum-based chemotherapy
  • Patients must have completed definitive chemotherapy and/or radiation therapy >= 3 months prior to study entry
  • Prior therapy with agents targeting/blocking the epidermal growth factor receptor (e.g. cetuximab and erlotinib) is allowable
  • Performance Status: Eastern Cooperative Oncology Group (ECOG) 0 - 2
  • Expected life expectancy of at least 12 weeks, as assessed by the Investigator
  • Ability and willingness to comply with the study's visit and assessment schedule and to provide voluntary written informed consent
  • Absolute neutrophil count (ANC) >= 1,500 cells/μL
  • Platelet count >= 75,000 cells/μL
  • Hemoglobin >= 8.0 g/dL
  • Creatinine =< 2.0 mg/dL
  • Total bilirubin =< 2.0 x upper limit of normal (ULN)
  • Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]), serum glutamic pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) =< 2.5 x ULN
  • For patients with liver metastases, AST, ALT < 5x ULN is acceptable
  • Willingness to use a medically acceptable method of contraception throughout the study period and for 4 weeks after the final administration of VTX-2337 (all subjects)
  • For female subjects with reproductive potential: a negative serum pregnancy test
Exclusions (conditions that would prevent participation in this study)
  • Investigational therapy within 4 weeks of study entry
  • Chemotherapy therapy within the previous 3 weeks or palliative radiation therapy within the previous 2 weeks; major surgery within the past 4 weeks prior to dosing with cetuximab or VTX-2337; patients should have recovered from major toxicities of prior therapy
  • Concurrent symptomatic central nervous system (CNS) involvement, brain or meningeal metastases; treated CNS involvement which has been stable > 28 days off systemic steroids may be included
  • Major active psychiatric disorders which would limit compliance
  • Treatment with oral or parenteral corticosteroids within 2 weeks prior to dosing with VTX-2337 or a requirement for systemic immunosuppressive therapy for any reason
  • Active autoimmune disease
  • Clinically significant cardiac disease (e.g., congestive heart failure, unstable or uncontrolled angina, myocardial infarction) within 6 months of dosing with VTX-2337
  • Clinically significant ophthalmologic disease, defined as:
  • Current retinal vascular disorder, including active untreated diabetic retinopathy and/or
  • Previous or current uveitis
  • Infection requiring parenteral antibiotic therapy or causing fever (temp > 100.5 degrees Fahrenheit [F] or 38.1 degrees Celsius [C]) within 1 week prior to dosing with VTX-2337
  • Pregnant or breast-feeding females
  • Uncontrolled inter-current illness, pre-planned surgery or procedure requiring hospitalization during the study period, or any other condition or circumstance that could interfere with adherence to the study's procedures or requirements, or otherwise compromise the study's objectives
  • Second primary malignancy that is clinically detectable (not including in situ carcinoma of the cervix, non-melanoma skin cancer or low-grade [Gleason score =< 6] localized prostate cancer) and demonstrating active progression at the time of consideration for study enrollment
  • Known prior severe allergic/hypersensitivity to cetuximab or any of the components of the study treatment
Last Updated
September 03, 2014
See this trial at ClinicalTrials.gov
Access protocol and consent forms at Fred Hutchinson Cancer Research Center
Disclaimer: We update this information regularly. However, what you read today may not be completely up to date.

Please remember:
  • Talk to your health care providers first before making decisions about your health care.
  • Whether you are eligible for a research study depends on many things. There are specific requirements to be in research studies. These requirements are different for each study.