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.
A Study of JNJ-40346527 in Patients With Relapsed or Refractory Hodgkin Lymphoma
The purpose of this study is to determine the safety, pharmacokinetics, and preliminary efficacy information of JNJ-40346527 in patients with relapsed or refractory Hodgkin lymphoma.
Stanford is currently not accepting patients for this trial.
Stanford Investigator(s):
Intervention(s):
- drug: Phase 1, Cohort 1
- drug: Phase 1, Cohort 2
- drug: Phase 1, Cohort 3
- drug: Phase 1, Cohort 4
- drug: Phase 2
Eligibility
Inclusion Criteria:
- Patients with histopathologically confirmed initial diagnosis of Hodgkin lymphoma and who
have disease that has relapsed or is refractory that is progressing or active and requires
treatment after at least 1 appropriate therapy
Exclusion Criteria:
- Known brain metastases or leptomeningeal disease
- Other malignancy within past 5 years
- Has any condition that, in the opinion of the investigator, would make study
participation not be in the best interest (eg, compromise the well-being) of the
patient or that could prevent, limit, or confound the protocol-specified assessments
- QTc prolongation at screening or other factors that increase the risk of QT
prolongation such as diagnosis or family history of long-QT syndrome, diagnosed or
suspected congenital long QT syndrome, or concomitant use of medication that can
prolong the QT interval
- Taking CYP3A4 substrate drugs with a narrow therapeutic index (eg, alfentanil,
astemizole, sirolimus, tacrolimus, terfenadine)
Ages Eligible for Study
18 Years - N/A
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
Sarah Daadi
650-725-6456
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.