Metastatic Cancer Clinical Trial
Official title:
Pilot Study of Non-invasive Measurement of PD-L1 Levels With Positron Emission Tomography (PET) in Head and Neck Malignancies and Intracranial Metastases
Verified date | February 2024 |
Source | Yale University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study aims to determine the feasibility of non-invasive quantitative PD-L1 measurement using [a novel PD-L1 positron emission tomography (PET) tracer and perform immunohistochemistry based measurement of PD-L1 levels within resected lesions in head and neck cancer and brain metastases.
Status | Terminated |
Enrollment | 7 |
Est. completion date | January 31, 2024 |
Est. primary completion date | January 31, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria for Head and Neck Cancer: - Patients with resectable squamous cell carcinoma of the oropharynx (HPV positive and HPV negative). - Resectability will be confirmed by a surgical co-investigator. - If available, HPV-association determined by institutional p16 testing (CINtec antibody demonstrating strong and diffuse nuclear and cytoplasmic staining is at least 70% of cells). - Absolute neutrophil count (ANC) > 1500/microliter, absolute lymphocyte count (ALC) >1000/microliter, hemoglobin > 9 g/dl, platelets > 100,000/microliter. - aspartate aminotransferase (AST) and alanine transaminase (ALT) < 5 x upper limit of normal. Bilirubin < 1.5 x upper limit of normal. - Albumin > 0 g/dl. - Creatinine < 5 x upper limit of normal. - Women of child-bearing potential must have a negative serum pregnancy test within 7 days prior to treatment Inclusion Criteria for Brain Metastases: - Patients with brain metastases - Tumor size equal or greater than 1 cm - Resectability or need for laser interstitial thermal therapy (LITT) will be confirmed by a surgical co-investigator. - Absolute neutrophil count (ANC) > 1500/microliter, absolute lymphocyte count (ALC) >1000/microliter, hemoglobin > 9 g/dl, platelets > 100,000/microliter - AST and ALT < 5 x upper limit of normal. Bilirubin < 1.5 x upper limit of normal. - Albumin > 0 g/dl. - Creatinine < 5 x upper limit of normal. - Women of child-bearing potential must have a negative serum pregnancy test within 7 days prior to treatment Exclusion Criteria for Head and Neck Cancer: - Medical contraindication to surgery. - Full dose anticoagulation. - Concomitant invasive malignancy, or malignancy within 2 years except for hormonally responsive breast or prostate cancer, resected non-melanoma skin cancer, resected uterine cervical carcinoma. - Inability to give informed consent. - Prior systemic therapy, radiation or gross resection for the tumor under study. - Women may not be pregnant or breast-feeding. - Receipt of other systemic therapy including investigational agents, radiation or gross resection for treatment of the tumor under study. Exclusion Criteria for Brain Metastases: - Medical contraindication to brain surgery. - Full dose anticoagulation. - Inability to give informed consent. - Women may not be pregnant or breast-feeding. |
Country | Name | City | State |
---|---|---|---|
United States | Yale University PET Center | New Haven | Connecticut |
Lead Sponsor | Collaborator |
---|---|
Yale University | National Cancer Institute (NCI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Immunohistochemistry vs PET measure of PD-L1 levels within resected brain metastasis tumor cells | To establish lesion level correlation of IHC measures of total/tumor/inflammatory cell PD-L1 levels compared to PD-L1 (VT) on PET in brain metastases using Pearson correlation between pathology based measure and imaging based measure. | from with in 2 weeks perioperative up to postoperative | |
Primary | Non-invasive quantitative PD-L1 levels will be measured using PET measures (VT) of lesions for the groups of PD-L1 levels (PD-L1 =90% vs <1%, PD-L1 =50% vs <1%) in head and neck cancer primary lesions | To test the difference in non-invasive quantitative PD-L1 PET measures (VT) of lesions between different groups of PD-L1 levels (PD-L1 =90% vs <1%) in head and neck cancer primary lesions | from with in 2 weeks perioperative up to postoperative | |
Secondary | Immunohistochemistry vs PET measure of PD-L1 levels in head and neck cancer primary lesion | To establish lesion level association comparing immunohistochemistry measures of PD-L1 levels within primary head and neck cancer lesions and PD-L1 PET measures (VT) using Pearson correlation between pathology based measure and imaging based measure. | from with in 2 weeks perioperative up to postoperative | |
Secondary | Immunohistochemistry vs PET measure of PD-L1 levels in head and neck cancer locoregional neck metastatic lesions and resected normal lymph nodes | To establish lesion level association comparing immunohistochemistry measures of PD-L1 levels within locoregional metastases within the neck and resected normal lymph nodes (as the outcome) and PD-L1 PET measures (VT) using Pearson correlation between pathology based measure and imaging based measure. | from with in 2 weeks perioperative up to postoperative | |
Secondary | Immunohistochemistry vs PET measure of infiltrating inflammatory cells in head and neck cancer primary lesion | To establish lesion level association comparing the degree of tumor inflammatory cell infiltration seen on IHC in primary head and neck SCC lesions (as the outcome) and PD-L1 PET measures (VT) using Pearson correlation between pathology based measure and imaging based measure. | from with in 2 weeks perioperative up to postoperative | |
Secondary | Immunohistochemistry vs PET measure of infiltrating inflammatory cells in head and neck cancer locoregional neck metastatic lesions and resected normal lymph nodes | To establish lesion level association comparing the degree of tumor inflammatory cell infiltration on IHC in metastatic head and neck SCC lesion (as the outcomes) and PD-L1 PET measures (VT) using Pearson correlation between pathology based measure and imaging based measure. | from with in 2 weeks perioperative up to postoperative |
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