FNA Tumor Sampling for CD137 Modulation: A Pilot Study

Breast Cancer Clinical Trial

Official title:

FNA Tumor Sampling for CD137 Modulation: A Pilot Study

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01114256
• Other study ID #: VAR0053
• Secondary ID: SU-04072010-5602
• Status: Terminated
• Phase: N/A
• First received: April 23, 2010
• Last updated: August 1, 2017
• Start date: March 2010
• Est. completion date: January 2016

Study information

• Verified date: August 2017
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 83
• Est. completion date: January 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Adenocarcinoma
• Breast Cancer
• Colorectal Adenocarcinoma
• Head and Neck Cancer
• Head and Neck Cancers
• Head and Neck Neoplasms
• Lymphoma, Non-Hodgkin
• Non-Hodgkin Lymphoma

Intervention

Procedure:
• FNA Biopsy

Locations

Country	Name	City	State
United States	Stanford University School of Medicine	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	evaluation of change in CD137 positive NK cells in blood & tumors in response to therapeutic moAbs		12 months
Secondary	Evaluation of activation status of CD137 positive NK cells		12 months