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FNA Tumor Sampling for CD137 Modulation: A Pilot Study

This study has been terminated.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01114256
First Posted: May 3, 2010
Last Update Posted: August 3, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Stanford University
April 23, 2010
May 3, 2010
August 3, 2017
March 2010
January 2016   (Final data collection date for primary outcome measure)
evaluation of change in CD137 positive NK cells in blood & tumors in response to therapeutic moAbs [ Time Frame: 12 months ]
Same as current
Complete list of historical versions of study NCT01114256 on ClinicalTrials.gov Archive Site
Evaluation of activation status of CD137 positive NK cells [ Time Frame: 12 months ]
Same as current
Not Provided
Not Provided
 
FNA Tumor Sampling for CD137 Modulation: A Pilot Study
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.
Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:
peripheral blood, fine needle aspiration biopsy
Non-Probability Sample
Patients at Stanford Cancer Center with lymphoma, squamous cell carcinoma of the head and neck, HER2+ breast adenocarcinoma, colorectal adenocarcinoma, or other solid tumor.
  • Head and Neck Cancer
  • Breast Cancer
  • Head and Neck Cancers
  • Non-Hodgkin Lymphoma
  • Colorectal Adenocarcinoma
Procedure: FNA Biopsy
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.
Intervention: Procedure: FNA Biopsy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
83
January 2016
January 2016   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
21 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01114256
VAR0053
SU-04072010-5602 ( Other Identifier: Stanford University )
Not Provided
Not Provided
Not Provided
Stanford University
Stanford University
Not Provided
Principal Investigator: Dr. A. Dimitrios Colevas Stanford University
Stanford University
August 2017