FNA Tumor Sampling for CD137 Modulation: A Pilot Study



Status:Recruiting
Conditions:Breast Cancer, Cancer, Cancer, Lymphoma
Therapuetic Areas:Oncology
Healthy:No
Age Range:21 - Any
Updated:4/21/2016
Start Date:March 2010

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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.


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.
We found this trial at
1
site
291 Campus Dr
Stanford, California 94305
(650) 725-3900
Principal Investigator: Dimitrios Colevas
Phone: 650-736-1598
Stanford University School of Medicine Vast in both its physical scale and its impact on...
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from
Stanford, CA
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