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.

Human Embryonic Stem Cell-Derived Cardiomyocyte Therapy for Chronic Ischemic Left Ventricular Dysfunction

This clinical study will utilize a new cell therapy approach (Human embryonic stem cells derived cardiomyocytes or hESC-CMs) to improve survival and cardiac function in patients with chronic left ventricular dysfunction secondary to MI (Myocardial Infarction).

Stanford is currently accepting patients for this trial.

Intervention(s):

  • drug: Human Embryonic Stem Cell-Derived Cardiomyocyte 50M cells
  • drug: Human Embryonic Stem Cell-Derived Cardiomyocyte 150 cells
  • drug: Human Embryonic Stem Cell-Derived Cardiomyocyte 300M cells

Eligibility


Inclusion Criteria:

   - Be ≥ 21 and < 80 years of age.

   - Provide written informed consent.

   - Have a diagnosis of chronic ischemic left ventricular dysfunction secondary to MI as
   defined by previous myocardial infarction documented by an imaging study demonstrating
   coronary artery disease with corresponding areas of akinesis, dyskinesis, or severe
   hypokinesis.

   - Be a candidate for cardiac catheterization within 5 to 10 weeks of screening.

   - Have been treated with appropriate maximal medical therapy for heart failure or
   postinfarction left ventricular dysfunction. For beta-blockade, the patient must have
   been on a stable dose of a clinically appropriate beta-blocker for 3 months. For
   angiotensinconverting enzyme (ACE) inhibitors or angiotensin receptor blockers (ARBs)
   or angiotensin receptor neprilysin inhibitors (ARNIs) or have appropriate medical
   indication precluding use of one or both of these agents, the patient must have been
   on a stable dose of a clinically appropriate agent for 1 month or within no more than
   doubling the dose of any of ARB, ACE inhibitors, and ARNIs over the last 3 months.

   - Left ventricular ejection fraction below 40%.

   - Class II/III NYHA symptoms of heart failure within the 6 months prior to baseline
   testing.

   - Hospitalization in the past 6 months or NT pro-BNP > 1200 pg/mL, or >1600 pg/mL if
   atrial fibrillation was present.

   - Automated implantable cardioverter-defibrillator (AICD) in place.

Exclusion Criteria:

   - Have a baseline glomerular filtration rate < 35 ml/min/1.73 m2

   - Have a known, serious radiographic contrast allergy.

   - Have a prosthetic aortic valve or heart constrictive device.

   - Have a documented presence of aortic stenosis (aortic stenosis graded as 1.5 cm2 or
   less).

   - Have a documented presence of moderate to severe aortic insufficiency
   (echocardiographic assessment of aortic insufficiency graded as ≥+2).

   - Have evidence of a life-threatening arrhythmia in the absence of a defibrillator
   (nonsustained ventricular tachycardia ≥ 20 consecutive beats or complete second- or
   third-degree heart block in the absence of a functioning pacemaker) or QTc interval >
   550 ms on screening ECG.

   - AICD firing in the past 60 days prior to enrollment.

   - Be eligible for or require coronary artery revascularization.

   - Have a hematologic abnormality as evidenced by hematocrit < 25%, white blood cell <
   2,500/µl, or platelet values < 100,000/µl without another explanation.

   - Have liver dysfunction, as evidenced by enzymes (AST and ALT) greater than three times
   the ULN.

   - Have a coagulopathy (INR > 1.3) not due to a reversible cause (i.e., Coumadin).
   Patients on Coumadin will be withdrawn 5 days before the procedure and confirmed to
   have an INR < 1.3. Patients who cannot be withdrawn from Coumadin will be excluded
   from enrollment.

   - Have known allergies to penicillin or streptomycin.

   - Be an organ transplant recipient.

   - Have a history of organ or cell transplant rejection.

   - Have a clinical history of malignancy within 5 years (i.e., patients with prior
   malignancy must be disease-free for 5 years), except curatively-treated basal cell
   carcinoma, squamous cell carcinoma, or cervical carcinoma.

   - Have a non-cardiac condition that limits lifespan to < 1 year.

   - Be on chronic therapy with immunosuppressant medication, such as corticosteroids or
   TNFα antagonists.

   - Be serum-positive for HIV, hepatitis BsAg, or viremic hepatitis C.

   - Be currently participating (or participated within the previous 30 days) in an
   investigational therapeutic or device trial.

   - Be a female patient who is pregnant, nursing, or have child-bearing potential but is
   not using effective birth control.

   - Tested positive for SARS-CoV-2 within the last 30 days

Ages Eligible for Study

21 Years - 80 Years

Genders Eligible for Study

All

Now accepting new patients

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
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.