FNA Tumor Sampling for CD137 Modulation: A Pilot Study

NCT01114256 | Terminated

• 2 other identifiers: VAR0053SU-04072010-5602
• Study Type: observational
• Target: 83
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

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

  12 months

Secondary Outcomes (1)

• Evaluation of activation status of CD137 positive NK cells

  12 months

Study Arms (1)

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

Interventions

FNA Biopsy PROCEDURE

Fine needle aspiration (FNA) biopsies

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.
• Patients may not be taking therapeutic anticoagulation (target INR of \>=2) (warfarin or heparin).
• 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.

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

Related Publications (1)

• 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.

  PMID: 27831501 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

peripheral blood, fine needle aspiration biopsy

MeSH Terms

Conditions

Head and Neck Neoplasms; Breast Neoplasms; Lymphoma, Non-Hodgkin

Interventions

Biopsy, Fine-Needle

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Lymphoma; Neoplasms by Histologic Type; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Biopsy, Needle; Biopsy; Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Punctures; Investigative Techniques

Study Officials

• Dr. A. Dimitrios Colevas

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 23, 2010
• First Posted: May 3, 2010
• Study Start: March 1, 2010
• Primary Completion: January 1, 2016
• Study Completion: January 1, 2016
• Last Updated: August 3, 2017

Record last verified: 2017-08

Locations

US (1)