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 to Evaluate Tabelecleucel in Participants With Epstein-barr Virus-associated Diseases
The purpose of this study is to assess the efficacy and safety of tabelecleucel in participants with Epstein-Barr virus (EBV) associated diseases.
Stanford is currently accepting patients for this trial.
Stanford Investigator(s):
Intervention(s):
- biological: Tabelecleucel
Eligibility
Inclusion Criteria:
- Diagnosis of EBV+ disorder
- Eastern Cooperative Oncology Group performance status <= 3 for participants aged >= 16
years; Lansky score >= 20 for participants from >=1 year to < 16 years
- Adequate organ function test results, unless organ dysfunction is considered to be due
to the underlying EBV-associated disease by the investigator
Cohort-specific Inclusion Criteria:
- For participants with PID LPD:
- R/R or newly diagnosed PID LPD for whom the standard first-line therapy is
inappropriate, as determined by investigator. The LPD is confirmed by at least
biopsy-proven EBV+ LPD or positive cerebrospinal fluid (CSF) cytology with or
without radiographically measurable intracranial disease with EBV detected in
CSF.
- Participants with R/R disease must have had at least one prior line of systemic
therapy and one of the following: radiographic disease progression per Lugano
Classification (Cheson BD, et al. J Clin Oncol. 2014;27:3059) during or after
treatment or failure to achieve a CR or partial response (PR) (defined by Lugano
radiographic criteria) after standard first-line therapy
- Participant may have systemic disease only, systemic and CNS disease, or CNS
disease only
- For participants with AID LPD:
- R/R or newly diagnosed AID LPD for whom the standard first line therapy is
inappropriate, as determined by the investigator. The LPD is confirmed by at
least biopsy-proven EBV+ LPD or positive CSF cytology, with or without
radiographically measurable intracranial disease, with EBV detected in CSF.
- Participants with R/R disease must have had at least one prior line of systemic
therapy and one of the following: radiographic disease progression per Lugano
Classification during or after treatment or failure to achieve a CR or PR
(defined by Lugano radiographic criteria) after standard first-line therapy
- Participant may have systemic disease only, systemic and CNS disease, or CNS
disease only
- For participants with AID etiology or AID attributable to immunosenescence,
objective laboratory evidence of immunodeficiency
- For participants with CNS PTLD:
- R/R or newly diagnosed EBV+ CNS PTLD for whom the standard first-line therapy is
inappropriate, as determined by the investigator. The CNS PTLD is histologically
confirmed by at least biopsy-proven EBV+ CNS PTLD or positive CSF cytology with
or without radiographically measurable intracranial disease with EBV detected in
CSF.
- Participants with R/R disease must have had at least one prior line of systemic
therapy and one of the following: radiographic disease progression per Lugano
Classification during or after treatment or failure to achieve a CR or PR
(defined by Lugano radiographic criteria) after standard first-line therapy
- Participant may have systemic and CNS disease or CNS disease only
- For participants with EBV+ PTLD, including CD20-negative disease:
- Biopsy-proven EBV+ PTLD for whom standard first-line therapy (rituximab and/or
chemotherapy) is inappropriate, as determined by the investigator
- Participants must have systemic disease measurable per Lugano Classification
criteria, except when contraindicated or mandated by local practice, then MRI may
be used
- For participants with sarcoma, including LMS, or smooth muscle tumors:
- EBV+ sarcoma or smooth muscle tumor with rapidly progressive disease defined as
progressive disease per RECIST 1.1 criteria as documented radiographically within
a 6-month interval prior to enrollment
- Participants with newly diagnosed EBV+ sarcoma for whom the standard first-line
therapy is inappropriate, as determined by the investigator
- Biopsy-proven EBV+ sarcoma meeting one of the criteria's of pathologically
confirmed EBV+ Leiomyosarcoma or EBV+ sarcoma or smooth muscle tumor
- Measurable disease using diagnostic CT and/or MRI following RECIST 1.1 criteria
(Eisenhauer et al. 2009. Eur J Cancer 45[2]:228-247)
Exclusion Criteria:
- Currently active Burkitt, T-cell, natural killer/T-cell lymphoma/LPD, Hodgkin,
plasmablastic, transformed lymphoma, active hemophagocytic lymphohistiocytosis, or
other malignancies requiring systemic therapy
- Serious known active infections, defined as ongoing uncontrolled adenovirus infection
or infections requiring systemic therapy at the time of enrollment, or known history
of human immunodeficiency virus (HIV) infection
- Suspected or confirmed Grade >= 2 acute graft-versus-host disease (GvHD) per the
Center for International Blood and Marrow Transplant Research (CIBMTR) consensus
grading system or extensive chronic GvHD per National Institutes of Health (NIH)
consensus criteria at the time of the enrollment
- Need for vasopressor or ventilatory support at the time of enrollment
- Prior therapy (in order of increasing washout period) prior to enrollment as follows:
- Within 4 weeks or 5 half-lives (whichever is shorter) for any investigational
product and/ or any chemotherapy (systemic or intrathecal), targeted small
molecule therapy, or antibody/biologic therapy. Note: prior anti-CD20 antibody
use is permitted within the washout period if a subsequent disease response
assessment indicates disease progression
- Within 8 weeks: prior tabelecleucel (>8 weeks prior to enrollment) is permitted
if response was obtained or if usual protocol-directed therapeutic options were
not exhausted, for cellular therapies (chimeric antigen receptor therapies
directed at T-cells or T-cell subsets, donor lymphocyte infusion, other CTLs or
virus-specific T-cells); and/or therapies which could impact tabelecleucel
function (anti-thymocyte globulin, alemtuzumab)
- Any prior treatment with EBV-CTLs with the exception of tabelecleucel as above
- Women who are breastfeeding or pregnant
- Unwilling to comply with protocol specified contraceptive/reproductive restrictions
from enrollment through 90 days after the last treatment
- Ongoing need for daily steroids of > 0.5 mg/kg prednisone or glucocorticoid
equivalent, ongoing methotrexate, or extracorporeal photopheresis (for participants
with CNS disease, protocol-specified dexamethasone is permitted and concludes by the
time of enrollment)
- Any conditions that may put the study outcomes at undue risk (life expectancy < 60
days or any life-threatening illness, medical condition, or organ system dysfunction)
- For participants with PID LPD or AID LPD: history of prior allogeneic HCT or solid
organ transplant
- For participants with EBV+ PTLD: prior systemic therapy for PTLD
Ages Eligible for Study
N/A - N/A
Genders Eligible for Study
All
Now accepting new patients
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Lianna Marks, MD
650-497-8953
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.