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.
A Safety and Efficacy Study of Ibrutinib in Pediatric and Young Adult Participants With Relapsed or Refractory Mature B-cell Non-Hodgkin Lymphoma
The purpose of this study is to confirm that the pharmacokinetics of ibrutinib in pediatric participants is consistent with that in adults (part 1) and to assess efficacy (event-free survival [EFS]) of ibrutinib in combination with rituximab, ifosfamide, carboplatin, and etoposide (RICE) or rituximab, vincristine, ifosfamide, carboplatin, and idarubicin (RVICI) background therapy compared to RICE or RVICI background therapy alone (part 2).
Stanford is currently not accepting patients for this trial.
Stanford Investigator(s):
Intervention(s):
- drug: Ibrutinib
- drug: Rituximab
- drug: Ifosfamide
- drug: Carboplatin
- drug: Etoposide
- drug: Vincristine
- drug: Idarubicin
- drug: Dexamethasone
Eligibility
Inclusion Criteria:
- Participants with 1 to less than (<) 18 years of age (Part 1 only), or 1 to 30 years
of age, inclusive, if initial diagnosis of mature B-cell non-Hodgkin lymphoma (NHL)
occurred at <18 years of age (Part 2 only)
- Participants must be in first recurrence and have received only one prior line of
therapy or have disease that is primarily refractory to conventional therapy
- Participants must have at least 1 of the following: 1 site of measurable disease
greater than (>) 1 centimeter (cm) in the longest diameter and >1 cm in the shortest
diameter by radiological imaging; bone marrow involvement; cerebrospinal fluid with
blasts present
- Participants with lansky-Karnofsky score of greater than or equal to (>=) 50
- Adolescent women/young women of childbearing potential must have a negative highly
sensitive serum or urine beta-human chorionic gonadotropin (beta-hCG) pregnancy test
at Screening before enrollment/randomization. Adolescent/young women who are pregnant
or breastfeeding are ineligible for this study
Exclusion Criteria:
- Participants with ongoing anticoagulation treatment with warfarin or equivalent
vitamin K antagonists (example phenprocoumon), or ongoing treatment with agents known
to be strong CYP3A4/5 inhibitors, or has taken any disallowed therapies as noted in
Section 8.2, Prohibited Medications, before the planned first dose of study drug
- Participants with inherited or acquired bleeding disorders
- Participants with clinically significant arrhythmias, complex congenital heart
disease, or left ventricular ejection fraction (LVEF) <50 percent (%) or shortening
fraction (SF) <=28%
- Participants with known history of human immunodeficiency virus (HIV) or active
Hepatitis B or C virus
- Participants with any condition that could interfere with the absorption or metabolism
of ibrutinib including malabsorption syndrome, disease significantly affecting
gastrointestinal function, or resection of the stomach or small bowel
- Participants with known allergies, hypersensitivity, or intolerance to ibrutinib or
its excipients (refer to Investigator's Brochure)
- A diagnosis of post-transplant lymphoproliferative disease (PTLD)
- Participants who are within 6 months of an allogeneic bone marrow transplant
- Participants who have had prior exposure to ibrutinib
Ages Eligible for Study
1 Year - 30 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
Christina Baggott
650-497-7659
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.