FNA Tumor Sampling for CD137 Modulation: A Pilot Study

Not Recruiting

Trial ID: NCT01114256


The purpose of this study is to better understand the biology of the body's immune response to monoclonal antibody therapy for cancer. Your health information will be used to identify your tissues. The tissue we obtain may be useful for research or education, resulting in new drugs, therapies or diagnostic procedures.

Official Title

FNA Tumor Sampling for CD137 Modulation: A Pilot Study

Stanford Investigator(s)

A. Dimitrios Colevas, MD
A. Dimitrios Colevas, MD

Professor of Medicine (Oncology) and, by courtesy, of Otolaryngology - Head & Neck Surgery (OHNS) and of Radiation Oncology (Radiation Therapy)

Christina Kong
Christina Kong

Professor of Pathology


ALL Patients:

   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
   the study.

   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
   or heparin).

   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

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Risa Jiron

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