Stanford APBI Trial
Clinical Trial
Overview
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.
Efficacy and Safety of Targeted Intramyocardial Delivery of Auto CD34+ Stem Cells for Improving Exercise Capacity in Subjects With Refractory Angina
The purpose of the study is to assess the safety and efficacy of targeted intramyocardial delivery of Auto-CD34+ cells for increasing exercise time and amelioration of anginal symptoms in subjects with refractory angina and chronic myocardial ischemia.
Stanford is currently accepting patients for this trial.
Intervention(s):
- biological: Auto-CD34+ cells
- biological: Placebo: Diluent used to suspend Auto-CD34+ cells
- other: Standard of care
Eligibility
Main Inclusion Criteria:
- Male or female participants who are 21 to 80 years of age at the time of signing the
informed consent.
- Participants with Canadian Cardiovascular Society (CCS) class III or IV chronic
refractory angina.
- Participants without control of their angina symptoms in spite of maximal tolerated
doses of anti-angina drugs. Participants must be on optimal therapy for their angina
and must have been on a stable anti-anginal medication regimen for at least 4 weeks
before signing the informed consent form.
- Participants with obstructive coronary disease unsuitable for conventional
revascularization due to unsuitable anatomy or comorbidity as determined at the site
and confirmed by an independent adjudication committee.
- Participants must have evidence of inducible myocardial ischemia.
- Participants must experience angina episodes.
- Participants must be able to complete 2 exercise tolerance tests on the treadmill
within 3 weeks of randomization.
- If female of childbearing potential, subject must not be pregnant and agree to employ
adequate birth control measures for the duration of the study.
Main Exclusion Criteria:
- Cardiovascular hospitalization within 60 days prior to potential study enrollment.
Participant has had a successful or partially successful coronary artery bypass graft
(CABG) within 6 months or PCTA within 60 days of potential study enrollment.
- Participant has had a placement of a bi-ventricular pacemaker for cardiac
resynchronization therapy (CRT) for heart failure within 180 days of potential study
enrollment.
- Participant has documented stroke or transient ischemic attacks (TIAs) within 60 days
of potential study enrollment.
- Participant has a history of moderate to severe aortic stenosis; or severe aortic
insufficiency; or severe mitral stenosis; or severe mitral insufficiency.
- Participant has a prosthetic aortic valve or a mechanical mitral valve replacement.
- Participant has severe co-morbidity associated with a reduction in life expectancy to
less than 3 years as a result of chronic medical illnesses.
- Participants with cancer are excluded with the following exceptions:
- Subjects with in-situ non-melanoma skin cancer or in-situ cervical cancer are not
excluded.
- Participants that have been cancer free for >= 5 years as determined by their
oncologist are not excluded. Subjects with a prior history of stem cell
transplant for cancer are excluded no matter how long they have been cancer-free.
- Participants with a history of leukemia or other bone marrow disease.
- Participant has sickle cell disease or sickle cell trait.
- Participants with proliferative retinopathy.
- Participants with Hb A1c > 9%.
- Participant has platelet counts >10% above the upper limit of normal (ULN) or platelet
counts < 70,000.
- Participant has a hematocrit < 30% prior to potential study enrollment.
- Participant has a serum creatinine > 2.5 mg/dL prior to potential study enrollment.
- Participant tests positive for HIV, hepatitis B, or hepatitis C, or is on chronic
immunosuppressive medications, or has had a previous stem cell transplant.
- Participant has a known contraindication to Neupogen (filgrastim) or G-CSF.
- Participant was previously enrolled in an active treatment group of cell therapy
trials for cardiovascular disease including any phase of CD34+ stem cell trials.
- Left ventricular (LV) thickness of < 7 mm in the target areas of injection as measured
by during a 2-D echocardiogram (ECHO).
- Atrial fibrillation, atrial flutter, or other uncontrolled arrhythmias that would
prohibit accurate electromechanical mapping and NOGA-guided intramyocardial injection.
- Bleeding diathesis with an INR > 1.8 when not receiving anti-thrombotic therapy.
- Hepatic dysfunction as evidenced by elevated AST or ALT levels > 2.5 x ULN.
- Any previous transplant requiring immunosuppression.
- Disease state requiring chronic immunosuppression.
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
Lauren Davis
I'm interested
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.