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 Study to Evaluate the Safety and Tolerability of CAEL-101 in Patients With AL Amyloidosis
AL amyloidosis begins in the bone marrow where abnormal proteins misfold and create free light chains that cannot be broken down. These free light chains bind together to form amyloid fibrils that build up in the extracellular space of organs, affecting the kidneys, heart, liver, spleen, nervous system and digestive tract.
The primary purpose of this study is to determine the recommended dose of CAEL-101 to facilitate progression of further clinical trials and evaluate safety and tolerability of CAEL-101 in combination with the standard of care (SoC) cyclophosphamide-bortezomib-dexamethasone (CyBorD) chemotherapy and daratumumab .
Stanford is currently not accepting patients for this trial.
Stanford Investigator(s):
Intervention(s):
- drug: CAEL-101
- drug: Daratumumab
- drug: SoC: cyclophosphamide, bortezomib, and Dexamethasone (CyBorD)
Eligibility
Key Inclusion Criteria:
Each patient must meet the following criteria to be enrolled in this study.
1. AL amyloidosis Mayo stage I, II or IIIa
2. For Part A only, measurable hematologic disease defined by at least one of the
following:
1. involved/uninvolved free light chain difference (dFLC) > 5mg/dL or
2. free light chain (FLC) > 5mg/dL with abnormal Kappa/Lambda ratio or
3. serum protein electrophoresis (SPEP) m- spike > 0.5 g/dL Patients with confirmed
AL amyloid diagnosis without measurable disease may be enrolled with consultation
and approval by the Sponsor Medical Monitor or their designee.
3. a. For Part A, currently on and continuing OR planned to start concurrent chemotherapy
with CyBorD administered weekly as SoC. b. For Part B, currently on and continuing OR
planned to start concurrent chemotherapy with CyBorD and daratumumab administered as
SoC.
Key Exclusion Criteria:
Patients who meet any of the following criteria will not be permitted entry to the study.
1. Any form of secondary, hereditary, senile, localized, dialysis-related or leukocyte
chemotactic factor 2-related (ALECT2) amyloidosis
2. Meets the International Myeloma Working Group (IMWG) definition of multiple myeloma.
Patients with signs and/or symptoms attributable ONLY to amyloidosis and who do NOT
meet IMWG definition of smoldering myeloma may be enrolled upon approval of the
medical monitor.
3. Supine systolic blood pressure < 90 mmHg or symptomatic orthostatic hypotension,
defined as a decrease in systolic blood pressure upon standing of > 20 mmHg despite
medical management (e.g., midodrine, fludrocortisones) in the absence of volume
depletion
4. Receiving dialysis
5. Myocardial infarction, uncontrolled angina, severe uncontrolled ventricular
arrhythmias, or percutaneous cardiac intervention with recent stent, coronary artery
bypass grafting or major cerebrovascular accident within 6 months prior to screening
6. Left ventricular ejection fraction (LVEF) < 45 percent by echocardiogram or multigated
acquisition scan (MUGA)
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
Mani Gupta
650-723-0501
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.