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FNA Tumor Sampling for CD137 Modulation: A Pilot Study

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ClinicalTrials.gov Identifier: NCT01114256
Recruitment Status : Terminated
First Posted : May 3, 2010
Last Update Posted : August 3, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Head and Neck Cancer Breast Cancer Head and Neck Cancers Non-Hodgkin Lymphoma Colorectal Adenocarcinoma Procedure: FNA Biopsy

Study Design

Study Type : Observational
Actual Enrollment : 83 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: FNA Tumor Sampling for CD137 Modulation: A Pilot Study
Study Start Date : March 2010
Primary Completion Date : January 2016
Study Completion Date : January 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy
U.S. FDA Resources

Groups and Cohorts

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


Outcome Measures

Primary Outcome Measures :
  1. evaluation of change in CD137 positive NK cells in blood & tumors in response to therapeutic moAbs [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Evaluation of activation status of CD137 positive NK cells [ Time Frame: 12 months ]

Biospecimen Retention:   Samples With DNA
peripheral blood, fine needle aspiration biopsy

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01114256


Locations
United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Investigators
Principal Investigator: Dr. A. Dimitrios Colevas Stanford University
More Information

Responsible Party: Stanford University
ClinicalTrials.gov Identifier: NCT01114256     History of Changes
Other Study ID Numbers: VAR0053
SU-04072010-5602 ( Other Identifier: Stanford University )
First Posted: May 3, 2010    Key Record Dates
Last Update Posted: August 3, 2017
Last Verified: August 2017

Additional relevant MeSH terms:
Adenocarcinoma
Lymphoma, Non-Hodgkin
Head and Neck Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Lymphoma
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Neoplasms by Site