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New treatment option for HPV-Negative Squamous Cell Carcinoma
Official title Personalized, Adaptive Treatment for Locally Advanced Head and Neck Cancer
ClinicalTrials.gov ID: NCT06005324
What this study is testing
What is Paclitaxel?
Paclitaxel is an investigational medicine, being studied as a potential treatment for hpv-negative squamous cell carcinoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This clinical trial will assess whether or not blood based biomarker testing can be used to personalize cancer treatment for patients with locally advanced head and neck cancer.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Patients must have pathologically confirmed locally advanced, non-metastatic, human papillomavirus (HPV) negative head and neck squamous cell...
- Stage III or IV disease based on American Joint Committee on Cancer (AJCC) staging 8th edition.
- If a primary oropharyngeal squamous cell carcinoma is diagnosed, HPV must be ruled out by immunohistochemistry.
- Availability of ≥10 unstained 5 micron slides. Patients who cannot fulfill this requirement will need to undergo a new biopsy prior to enrollment on...
- Patients must be at least 18 years of age.
You likely can't join if
- Unequivocal demonstration of distant metastatic disease (M1 disease).
- Unidentifiable primary site.
- Intercurrent medical illnesses which would impair patient tolerance to therapy or limit survival. This includes but is not limited to ongoing or...
- Prior surgical therapy other than incisional/excisional biopsy or organ-sparing procedures such as debulking of airway-compromising tumors. Residual...
- Patients receiving other investigational agents.
- Diagnosis of immunodeficiency or is receiving systemic steroid therapy in excess of physiologic dose or any other form of immunosuppressive therapy...
See the full eligibility criteria
- Patients must have pathologically confirmed locally advanced, non-metastatic, human papillomavirus (HPV) negative head and neck squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, nasopharynx, larynx...
- Stage III or IV disease based on American Joint Committee on Cancer (AJCC) staging 8th edition.
- If a primary oropharyngeal squamous cell carcinoma is diagnosed, HPV must be ruled out by immunohistochemistry.
- Availability of ≥10 unstained 5 micron slides. Patients who cannot fulfill this requirement will need to undergo a new biopsy prior to enrollment on study.
- Patients must be at least 18 years of age.
- Measurable disease (either primary site and/or nodal disease) by RECIST 1.1 criteria.
- No previous radiation or chemotherapy for a head and neck cancer.
- No complete surgical resection for a head and neck cancer within 8 weeks of enrollment (although lymph node biopsy including excision of an individual node with presence of residual nodal disease, or surgical...
- Performance status 0-1
- Normal Organ Function
- Leukocytes ≥ 3000/mm3
- Platelets ≥ 100,000/mm3
- Absolute neutrophil count ≥ 1,500
- Hemoglobin ≥ 9.0 gm/dL
- Aspartate Aminotransferase (AST) ≤ 2.5x upper limit of normal
- Alanine aminotransferase (ALT) ≤ 2.5x upper limit of normal
- Alkaline phosphatase ≤ 2.5x upper limit of normal
- Albumin \> 2.9 gm/dL
- Total bilirubin ≤ 1.5 mg/dL
- Creatinine clearance (CrCl) \> 45 mL/min, normal within 2 weeks prior to start of treatment (Of note, the standard Cockcroft and Gault formula must be used to calculate CrCl for enrollment or dosing)
- Patients must sign a study-specific informed consent form prior to study entry. Patients should have the ability to understand and the willingness to sign a written informed consent document.
- Women of childbearing potential must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 24 hours prior to the start of study drug.
- Women must not be breastfeeding
- Women of childbearing potential must agree to follow instructions for method(s) of contraception for the duration of treatment with study drug(s) plus 5 months after completing chemoradiation or receiving the last dose...
- Men who are sexually active with women of childbearing potential must agree to follow instructions for method(s) of contraception for the duration of treatment with study drug(s) plus 5 months after completing...
- Unequivocal demonstration of distant metastatic disease (M1 disease).
- Unidentifiable primary site.
- Intercurrent medical illnesses which would impair patient tolerance to therapy or limit survival. This includes but is not limited to ongoing or active infection, immunodeficiency, symptomatic congestive heart failure...
- Prior surgical therapy other than incisional/excisional biopsy or organ-sparing procedures such as debulking of airway-compromising tumors. Residual measurable tumor is required for enrollment as discussed above.
- Patients receiving other investigational agents.
- Diagnosis of immunodeficiency or is receiving systemic steroid therapy in excess of physiologic dose or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment.
- Known history of active tuberculosis (Bacillus Tuberculosis infection).
- Hypersensitivity to cetuximab or any other drug used in this protocol.
- Prior systemic anti-cancer treatment within the last 8 weeks.
- Has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative...
- Has a history of HIV.
- Has known active Hepatitis B or Hepatitis C. If eradicated, patient is eligible.
- Has received a live vaccine within 28 days of planned start of study therapy.
The study team makes the final eligibility decision.
Where it's taking place
- Chicago, Illinois, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chicago, Illinois, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.