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.
Emicizumab for Severe Von Willebrand Disease (VWD) and VWD/Hemophilia A
Von Willebrand Disease (VWD) is the most common inherited bleeding disorder affecting up to 0.1% of the population, is usually characterized by mucocutaneous bleeding, HMB, surgical bleeding or other hemostatic challenges. Severe bleeding events require VWF concentrates administered solely through intravenous access. Emicizumab (Hemlibra) is a monoclonal bispecific antibody developed to bind activated FIX and FX and mimic FVIII cofactor functionality. Hemlibra is administered via subcutaneous injection rather than intravenous infusion. The hypothesis of this study is that Emicizumab is safe and efficacious for prophylaxis in severe VWD and concomitant VWD/hemophilia patients.
Stanford is currently accepting patients for this trial.
Stanford Investigator(s):
Intervention(s):
- drug: Emicizumab
Eligibility
Inclusion Criteria:
- Signed informed consent
- age >/= 2
- ability to comply with protocol in investigators judgement
- diagnosis of: severe VWD type 3, or VWD with VWF antigen, activity or collagen binding
50 U/dl based on historical medical records of study site.
- diagnosis of VWD/hemophilia A defined as VWF:ag, activity or CB <50 U/dl, and mild
moderate or severe hemophilia A(defined by ISTH criteria) based on historical medical
records of the study site.
- plan to be adherent to emicizumab prophylaxis during the study
- Patient's bleeding phenotype necessitating prophylaxis per treating provider
recommendations.
- Patient on current prophylaxis for VWD or VWD/hemophilia A may enroll if they are
currently on a ono-emicizumab agent, and if it has been > 18 months since last
off-label dose of emicizumab, and are willing to discontinue current prophylaxis.
- For menstruating individuals: agreement to remain abstinent (refrain from heterosexual
intercourse) or use contraceptive methods that result in a failure rate of < 1% per
year during the study period. A mensturating individual is considered to be of
childbearing potential if they are post-menarchal, have not reached a postmenopausal
state (12 continuous months of amenorrhea with no identified cause other than
menopause), and have not undergone surgical sterilization (removal of ovaries and/or
uterus).
Examples of highly effective contraceptive methods with a failure rate of < 1% per year
include proper use of combined oral or injected hormonal contraceptive, bilateral tubal
ligation, male sterilization, hormone-releasing intrauterine devices, and copper
intrauterine devices. The reliability of sexual abstinence should be evaluated in relation
to the duration of the clinical trial and the preferred and usual lifestyle of the patient.
Periodic abstinence (e.g., calendar, ovulation, symptothermal, or post-ovulation methods)
and withdrawal are not acceptable methods of contraception.
Exclusion Criteria:
- Patients age <2 years of age.
- Patients with low VWF or non-severe VWD (ie.not meeting the above criteria)
- Other concomitant bleeding disorders including coagulopathy from liver cirrhosis.
- Current treatment with emicizumab or emicizumab therapy in the previous 18 months.
- Previous (in the past 12 months) or current treatment for thromboembolic disease (with
the exception of previous catheter-associated thrombosis for which anti-thrombotic
treatment is not currently ongoing) or current signs of thromboembolic disease
- Other conditions (e.g., certain autoimmune diseases, including, but not limited to
diseases such as systemic lupus erythematosus, inflammatory bowel disease, and
antiphospholipid syndrome) that may increase the risk of bleeding or thrombosis
- Patients who are at high risk for thrombotic microangiopathy (TMA; e.g., have a
previous medical or family history of TMA), in the investigator's judgment
- Would refuse treatment with blood or blood products, if necessary.
- Any serious medical condition or abnormality in clinical laboratory tests that, in the
investigator's judgment, precludes the patient's safe participation in and completion
of the study
- Treatment with any of the following:
An investigational drug to treat or reduce the risk of hemophilic bleeds within 5
half-lives of last drug administration before Study Day 1 A non-hemophilia-related
investigational drug within the last 30 days or 5 halflives- before Study Day 1, whichever
is longer An investigational drug concurrently
- History of clinically significant hypersensitivity associated with monoclonal antibody
therapies or components of the emicizumab injection
- Pregnant or lactating, or intending to become pregnant during the study
- Women of childbearing potential must have a negative serum pregnancy test result
within 7 days before Study Day 1
- Illicit drug or alcohol abuse within 12 months prior to screening, in the
investigator's judgment
- Serious infection requiring oral or IV antibiotics within 30 days prior to screening
Ages Eligible for Study
2 Years - 90 Years
Genders Eligible for Study
All
Now accepting new patients
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
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.