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©2022 Stanford Medicine
Trial ID: NCT01114256
FNA Tumor Sampling for CD137 Modulation: A Pilot Study
Professor of Medicine (Oncology) and, by courtesy, of Otolaryngology - Head & Neck Surgery (OHNS) and of Radiation Oncology (Radiation Therapy)
Professor of Pathology
1. Patient must have a lymphoma, squamous cell carcinoma of the head and neck, HER2+
breast adenocarcinoma, colorectal adenocarcinoma, or other solid tumor.
2. Patients must not have received any immunosuppressive or anti cancer agent within 2
weeks prior to the first planned FNA biopsy.
3. The patient's therapeutic plan must include a standard therapeutic monoclonal antibody
(such as rituximab, cetuximab/panitumumab or trastuzumab) or an investigational
monoclonal antibody) to be administered on a schedule such that a FNA biopsy can be
done within one week prior, and/or peripheral blood drawn immediately prior to the
first dose of the therapeutic mAb and immediately to 24-336 hours post dose. Patients
not receiving any other anti- cancer or immunosuppressive (steroids) modality within
that time frame are preferred, though use of such agents does not exclude them from
4. Patients not receiving any immunosuppressive or anti-cancer agent within 2 weeks prior
to the first planned FNA biopsy are preferred.
5. Informed consent must occur and be documented per institutional rules prior to the
first planned FNA biopsy and blood draw.
Patients Providing an FNA in addition to Blood Samples: Criteria applicable to FNA, and not
required for patients providing PBMCs without FNA. Patients without tumors amenable to FNA
will be candidates for blood sampling only.
If patients do not meet inclusion criteria, then they will be excluded from participating
in this study.
1. Patients must have a normal WBC and platelet count, must have no evidence of
coagulopathy and must not have received irreversible platelet inhibitors (aspirin) for
2 weeks and reversible platelet inhibitors (other NSAIDS) for one week prior to the
initial FNA biopsy.
2. Patients may not be taking therapeutic anticoagulation (target INR of >=2) (warfarin
3. Patients must have tumor masses amenable to minimally invasive fine needle aspiration
by direct visualization and/ or palpation of the tumor. Generally this will be a
biopsy of the primary tumor site or superficial regional lymph nodes.
procedure: FNA Biopsy
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