Stanford APBI Trial

Clinical Trial

Overview

Intraoperative Radiotherapy (IORT) is one of three approaches used for accelerated, partial breast irradiation at Stanford.

Accelerated, partial breast irradiation (APBI) is a potentially important new way to incorporate radiotherapy in the treatment of women with breast cancer.

Currently, women with breast cancer who undergo a lumpectomy  typically have 6 1/2 weeks of radiation to the entire affected breast after surgery.  Accelerated, partial breast irradiation (APBI) changes this approach in two ways. It shortens the treatment time from 6 1/2 weeks to between 1 to 5 days, and reduces the treatment area from the entire breast to the area of the breast immediately around the lumpectomy site. This is the part of the breast where most cancers are likely to recur.

In many ways APBI is to current whole breast radiotherapy what a lumpectomy is to a mastectomy. The goal is to use a less invasive more focused treatment without compromising survival.

APBI has been used in limited trials in several hundred patients over the last 10 years. These trials show that in properly selected breast cancer patients APBI  worked just as well as whole breast radiotherapy. In the initial studies, investigators relied on the placement of many catheters in the breast tissue (interstial brachytherapy). Newer techniques will hopefully provide the same good results but will deliver the radiation in faster and/or more convenient ways. This could increase interest in APBI and allow additional clinical trials that test the safety and effectiveness of the newer approaches. These newer approaches could increase quality of life for many women with breast cancer.

Investigators at Stanford University Medical Center are currently offering an IRB approved clinical trial that uses three new approaches for APBI. These three approaches are:

    Intraoperative Radiotherapy (IORT) - 1 day

    Intracavitary Brachytherapy (MammoSite) - 5 days

    3-D Conformal/External Beam Radiotherapy - 5 days

The Stanford trial is led by Dr. Frederick Dirbas, Assistant Professor of Surgery, and by Dr. Donald Goffinet, Professor of Radiation Oncology. For further information about the trial please contact Janelle Maxwell or Triona Dolphin at (650) 498-7740.

Adaptive Immune Responses and Repertoire in Influenza Vaccination and Infection (SLVP031)

The purpose of this study is provide a better understanding of the adaptive immune response to the licensed flu vaccines. The investigators hope the information learned from this study will help identify and describe important factors of influenza immunity especially of or specific proteins associated with the T-cell immune response.

Stanford is currently not accepting patients for this trial.

Intervention(s):

  • biological: Fluzone®
  • biological: FluMist®

Eligibility


Inclusion Criteria:

   1. Otherwise healthy 18-49 years old identical (MZ) twins identified as DR1501+ or
   DR0701+ by lab assay results. Both twins in the pair must be willing to participate in
   the study.

   2. Willing to complete the informed consent process

   3. Availability for follow-up for the planned duration of the study

   4. Acceptable medical history by review of inclusion/exclusion criteria and vital signs.

Exclusion Criteria:

   1. Prior off-study vaccination with the current year's seasonal influenza vaccine.

   2. Allergy to egg or egg products or to vaccine components including gentamicin, gelatin,
   arginine or MSG

   3. Life-threatening reactions to previous influenza vaccinations

   4. Asthma (a contraindication for receipt of LAIV4)

   5. Active systemic or serious concurrent illness, including febrile illness on the day of
   vaccination

   6. History of immunodeficiency (including HIV infection)

   7. Known or suspected impairment of immunologic function, including, but not limited to,
   clinically significant liver disease, diabetes mellitus treated with insulin, moderate
   to severe renal disease, or any other chronic disorder which, in the opinion of the
   investigator, might jeopardize volunteer safety or compliance with the protocol.

   8. Blood pressure >150 systolic or >95 diastolic at first study visit and the day of
   vaccination.

   9. Hospitalization in the past year for congestive heart failure or emphysema.

10. Chronic Hepatitis B or C.

11. Recent or current use of immunosuppressive medication, including systemic
   glucocorticoids (corticosteroid nasal sprays and topical steroids are permissible in
   all groups; inhaled steroid use is not permissible)

12. Participants who care for severely immunosuppressed persons that require a protective
   environment should not receive LAIV, or should avoid contact with such persons for 7
   days after receipt, given the theoretical risk for transmission of the live attenuated
   vaccine virus to close contacts. [If yes, may be ineligible]

13. Malignancy, other than squamous cell or basal cell skin cancer (includes solid tumors
   such as breast cancer or prostate cancer with recurrence in the past year, and any
   hematologic cancer such as leukemia).

14. Autoimmune disease (including rheumatoid arthritis treated with immunosuppressive
   medication such as Plaquenil, methotrexate, prednisone, Enbrel) which, in the opinion
   of the investigator, might jeopardize volunteer safety or compliance with the
   protocol.

15. History of blood dyscrasias, renal disease, or hemoglobinopathies requiring regular
   medical follow up or hospitalization during the preceding year

16. Use of any anti-coagulation medication such as Coumadin or Lovenox, or anti-platelet
   agents such as aspirin (except up to 325 mg. per day), Plavix, or Aggrenox must be
   reviewed by investigator to determine if this would affect the volunteer's safety.

17. Has taken an influenza antiviral medication within 48 hours prior to study vaccination
   [If yes, may not eligible if unable to schedule at an appropriate interval].

18. Receipt of blood or blood products within the past 6 months or planned used during the
   study.

19. Medical or psychiatric condition or occupational responsibilities that preclude
   participant compliance with the protocol

20. Receipt of an inactivated vaccine 14 days prior to study enrollment, or planned
   vaccinations prior to completion of last study visit ( ~ 28 days after study
   vaccination)

21. Receipt of a live, attenuated vaccine within 60 days prior to enrollment of planned
   vaccination prior to completion of last study visit (~ 28 days after study
   vaccination)

22. Need for allergy immunization (that cannot be postponed) during the study period.

23. History of Guillain-Barré syndrome

24. Pregnant or lactating woman

25. Use of investigational agents within 30 days prior to enrollment or planned use during
   the study.

26. Donation of the equivalent of a unit of blood within 6 weeks prior to enrollment or
   planned donation prior to completion of the last visit.

27. Any condition which, in the opinion of the investigator, might interfere with
   volunteer safety, study objectives or the ability of the participant to understand or
   comply with the study protocol.

Ages Eligible for Study

18 Years - 49 Years

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Not Recruiting

What's New

Stanford’s APBI trial has now been expanded to include women with  ductal carcinoma in situ (DCIS). Please call 650-498-7740 for more information.