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FNA Tumor Sampling for CD137 Modulation: A Pilot Study

18 Years
Open (Enrolling)
Head and Neck Cancer, Breast Cancer, Head and Neck Cancers

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Trial Information

FNA Tumor Sampling for CD137 Modulation: A Pilot Study

Inclusion Criteria

ALL Patients:

1. Patient must have histologically confirmed CD20+ tumor (non-Hodgkin lymphoma),
squamous cell carcinoma of the head and neck, HER2+ breast adenocarcinoma, or
colorectal adenocarcinoma.

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 either rituximab, cetuximab/panitumumab
or trastuzumab 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 24-72 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.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

evaluation of change in CD137 positive NK cells in blood & tumors in response to therapeutic moAbs

Outcome Time Frame:

12 months

Safety Issue:


Principal Investigator

Dr. A. Dimitrios Colevas

Investigator Role:

Principal Investigator

Investigator Affiliation:

Stanford University


United States: Institutional Review Board

Study ID:




Start Date:

March 2010

Completion Date:

December 2013

Related Keywords:

  • Head and Neck Cancer
  • Breast Cancer
  • Head and Neck Cancers
  • Breast Neoplasms
  • Head and Neck Neoplasms



Stanford University School of MedicineStanford, California  94305-5317