FNA Tumor Sampling for CD137 Modulation: A Pilot Study

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.

Study Overview

• Status: Terminated
• Conditions: Breast Cancer; Head and Neck Cancer; Non-Hodgkin Lymphoma; Colorectal Adenocarcinoma; Head and Neck Cancers
• Intervention / Treatment: Procedure: FNA Biopsy

• Study Type: Observational
• Enrollment (Actual): 83

Contacts and Locations

Study Locations

• United States
  • California
    • Stanford, California, United States, 94305
      • Stanford University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients at Stanford Cancer Center with lymphoma, squamous cell carcinoma of the head and neck, HER2+ breast adenocarcinoma, colorectal adenocarcinoma, or other solid tumor.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Fine needle aspiration (FNA) biopsies; Fine needle aspiration biopsies (FNA) will be performed prior to and 0 to 336 hours after the therapeutic monoclonal antibody infusion.	Procedure: FNA Biopsy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
evaluation of change in CD137 positive NK cells in blood & tumors in response to therapeutic moAbs	12 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Evaluation of activation status of CD137 positive NK cells	12 months

Collaborators and Investigators

• Sponsor: Stanford University
• Investigators: Principal Investigator: Dr. A. Dimitrios Colevas, Stanford University

Publications and helpful links

General Publications

• Makkouk A, Sundaram V, Chester C, Chang S, Colevas AD, Sunwoo JB, Maecker H, Desai M, Kohrt HE. Characterizing CD137 upregulation on NK cells in patients receiving monoclonal antibody therapy. Ann Oncol. 2017 Feb 1;28(2):415-420. doi: 10.1093/annonc/mdw570.

Study record dates

Study Major Dates

• Study Start: March 1, 2010
• Primary Completion (Actual): January 1, 2016
• Study Completion (Actual): January 1, 2016

Study Registration Dates

• First Submitted: April 23, 2010
• First Submitted That Met QC Criteria: April 29, 2010
• First Posted (Estimate): May 3, 2010

Study Record Updates

• Last Update Posted (Actual): August 3, 2017
• Last Update Submitted That Met QC Criteria: August 1, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Head and Neck Neoplasms
• Other Study ID Numbers: VAR0053; SU-04072010-5602 (Other Identifier: Stanford University)