FNA Tumor Sampling for CD137 Modulation: A Pilot Study

Stanford University

Status: Terminated

Conditions: Breast Cancer; Colorectal Adenocarcinoma; Head and Neck Cancers; Head and Neck Cancer; Non-Hodgkin Lymphoma

Treatments: Procedure: FNA Biopsy

Study type: Observational

Funder types: Other

Identifiers

NCT01114256

VAR0053

SU-04072010-5602 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 83 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

83 participants in 1 patient group

Fine needle aspiration (FNA) biopsies

Description:

Fine needle aspiration biopsies (FNA) will be performed prior to and 0 to 336 hours after the therapeutic monoclonal antibody infusion.

Treatment:

Procedure: FNA Biopsy