FNA Tumor Sampling for CD137 Modulation: A Pilot Study
Head and Neck Cancer - Breast Cancer - Head and Neck Cancers
Conditions: official terms
Head and Neck Neoplasms
Study Type
Study Phase
Study Design
Allocation: Non-Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Name: FNA Biopsy
Type: Procedure
Overall Status
This research involves the study of cancer cells in order to better understand how the body's immune system responds to therapy with monoclonal antibodies. This study may lead to the development of special materials that could be used, in the future, to treat head and neck cancer or to follow the response to treatment.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
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.
Stanford University School of Medicine
Stanford, California, United States
Status: Recruiting
Contact: Risa Jiron - 650-736-1598 - rjiron@stanford.edu
Start Date
March 2010
Stanford University
Stanford University
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page