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FNA Tumor Sampling for CD137 Modulation: A Pilot Study

This study is currently recruiting participants.
Verified December 2012 by Stanford University
Sponsor:
Information provided by (Responsible Party):
Stanford University
ClinicalTrials.gov Identifier:
NCT01114256
First received: April 23, 2010
Last updated: December 11, 2012
Last verified: December 2012
History of Changes
  Purpose

Pilot study of biological changes in tumor lymphocytes after antibody treatment


Condition Intervention
Head and Neck Cancer
Breast Cancer
Head and Neck Cancers
 Procedure: FNA Biopsy

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: FNA Tumor Sampling for CD137 Modulation: A Pilot Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Stanford University:

Primary Outcome Measures:
  • evaluation of change in CD137 positive NK cells in blood & tumors in response to therapeutic moAbs [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Evaluation of activation status of CD137 positive NK cells [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 24
Study Start Date: March 2010
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: 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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

ALL Patients:

  1. Patient must have histologically confirmed CD20+ tumor (non-Hodgkin lymphoma), squamous cell carcinoma of the head and neck, HER2+ breast adenocarcinoma, or colorectal adenocarcinoma.
  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 either rituximab, cetuximab/panitumumab or trastuzumab 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 24-72 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01114256

Contacts
Contact: Ruth Lira (650) 723-1367 rlira@stanford.edu

Locations
United States, California
Stanford University School of Medicine Recruiting
Stanford, California, United States, 94305
Contact: Ruth Lira     650-723-1367     rlira@stanford.edu    
Contact: Cancer Clinical Trials Office     (650) 498-7061        
Principal Investigator: Dr. A. Dimitrios Colevas            
Sub-Investigator: Holbrook Kohrt            
Sub-Investigator: Dr. Ellie Guardino MD/PhD            
Sponsors and Collaborators
Stanford University
Investigators
Principal Investigator: Dr. A. Dimitrios Colevas Stanford University
  More Information

No publications provided

Responsible Party: Stanford University
ClinicalTrials.gov Identifier: NCT01114256     History of Changes
Other Study ID Numbers: VAR0053, SU-04072010-5602
Study First Received: April 23, 2010
Last Updated: December 11, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Breast Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
 Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on May 19, 2013