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.
Acid Lipase Replacement Investigating Safety and Efficacy (ARISE) in Participants With Lysosomal Acid Lipase Deficiency
This Phase 3 study evaluated the efficacy and safety of 1 milligram/kilogram (mg/kg) intravenous (IV) infusions of SBC-102 (sebelipase alfa) administered every other week (qow) in participants with late onset lysosomal acid lipase deficiency (LAL-D) (cholesteryl ester storage disease [CESD]).
Late-onset LAL-D is an underappreciated cause of cirrhosis, liver failure and dyslipidemia. There is currently no standard treatment for LAL-D other than supportive care. Enzyme replacement therapy may be a potential new treatment option for LAL-D participants.
Stanford is currently accepting patients for this trial.
Stanford Investigator(s):
Intervention(s):
- drug: Placebo
- drug: Sebelipase Alfa
Eligibility
Inclusion Criteria:
- Participant and/or participant's parent or legal guardian provided informed consent.
- Participant was ≥ 4 years of age on the date of informed consent.
- Deficiency of LAL enzyme activity confirmed by dried blood spot testing at screening.
- Alanine aminotransferase ≥ 1.5x upper limit of normal on 2 consecutive screening
measurements obtained at least 1 week apart.
- Female participants of childbearing potential must not have been pregnant or
breastfeeding and must have agreed to use a medically acceptable method of preventing
contraception from screening until 4 weeks after the last dose of study drug.
- Participant receiving lipid-lowering therapies must have been on a stable dose of the
medication for at least 6 weeks prior to randomization and was willing to remain on a
stable dose for at least the first 32 weeks of treatment in the study.
- Participant receiving medications for the treatment of nonalcoholic fatty liver
disease must have been on a stable dose for at least 16 weeks prior to randomization
and was willing to remain on a stable dose for at least the first 32 weeks of
treatment in the study.
Exclusion Criteria:
- Severe hepatic dysfunction (Child-Pugh Class C).
- Other medical conditions or comorbidities, which, in the opinion of the Investigator,
would have interfered with study compliance or data interpretation.
- Previous hematopoietic or liver transplant procedure.
- Received treatment with high-dose corticosteroids (acute or chronic) within 26 weeks.
(Note: Participants receiving maintenance therapy with low-dose oral, intranasal,
topical, or inhaled corticosteroids were considered eligible for the study).
- Known hypersensitivity to eggs.
- Participated in a study employing an investigational medicinal product within 4 weeks
prior to randomization.
Ages Eligible for Study
4 Years - N/A
Genders Eligible for Study
All
Now accepting new patients
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Greg Enns, MD
(650) 498-5798
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.