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.
Pharmacokinetics, Safety and Tolerability of Single-dose Belatacept in Adolescent Kidney Transplant Recipients
The purpose of this study is to evaluate how well adolescent kidney transplant patients tolerate a single dose of belatacept they receive at least 6 months after transplant surgery, and how their body handles the drug.
Stanford is currently not accepting patients for this trial.
Stanford Investigator(s):
Intervention(s):
- drug: Belatacept
Eligibility
For more information regarding BMS clinical trial participation, please visit
www.BMSStudyConnect.com
Inclusion Criteria:
- Male and Female subjects,12-17 years old
- Receiving CNI-based maintenance immunosuppression since the time of renal
transplantation in accordance with local standard of care
- Stable renal function, in the opinion of the investigator, with a cGFR>45
mL/min/1.73m2 at the time of enrollment (per updated Schwartz Formula)
- Adolescent Recipients of a renal allograft from a living donor or a deceased donor at
least 6 months prior to enrollment
- Subject must be receiving a calcineurin inhibitor (CNI)-based [cyclosporine (CsA) [any
formulation] or Tacrolimus (TAC)] immunosuppressive regimen
- Subject must be receiving adjunctive background maintenance immunosuppression with
mycophenolate mofetil (MMF) or enteric-coated mycophenolate sodium
(EC-MPS)/mycophenolic acid (MPA)
- Subjects may be receiving maintenance corticosteroids in accordance with the local
standard of care
- Negative Interferon Gamma Release Assay (IGRA) such as QuantiFERON-TB Gold test or
T-Spot-TB
- FOCBP must have negative serum or urine pregnancy test within 24 hrs prior to start of
study medication
- Subject must have stable estimated glomerular filtration rate (GFR) ≥45 mL/min/1.73m2
(updated Schwartz formula)
Exclusion Criteria:
- Epstein-Barr virus (EBV) serostatus negative or unknown at time of transplant and
screening
- History of any treated or biopsy proven acute rejection (BPAR) within 3 months prior
to enrollment
- Subjects who have experienced more than 1 episode of acute rejection (AR) of the
current allograft or any antibody-mediated AR
- Subjects with any active infection [including, but not limited to, positive
cytomegalovirus (CMV) or BK viral (BKV) loads, BKV associated nephropathy (BKVAN), CMV
retinitis, CMV colitis, etc.]
- Urine albumin:creatinine ratio > 56.5 mg/mmol (> 0.5 mg albumin / mg creatinine) on a
random voided urine specimen
Ages Eligible for Study
12 Years - 17 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
Paul Grimm, Site 0006
650-725-5295
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.