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 Trial of E7777 in Persistent and Recurrent Cutaneous T-Cell Lymphoma
The purpose of this trial is to assess the efficacy of E7777 in participants with recurrent or persistent Cutaneous T-Cell Lymphoma (CTCL) in Stage I - III participants as assessed by objective response rate (ORR). A lead-in dose-finding part was used to determine dose level 9 microgram per kilogram (mcg/kg) E7777 that is being used to test efficacy and safety.
Stanford is currently not accepting patients for this trial.
Stanford Investigator(s):
Intervention(s):
- drug: E7777 9 mcg/kg
Eligibility
Inclusion Criteria:
Participants must meet all of the following criteria to be included in the study:
1. Age greater than or equal to 18 years.
2. Histopathologic diagnosis of CTCL (mycosis fungoides [MF] or Sezary Syndrome [SS]),
confirmed by skin biopsy, or lymph node, or blood assessment, of current disease.
3. CD25 assay-positive tumor, defined as detectable CD25 on greater than or equal to 20%
of total lymphoid infiltrate in biopsied lesions by immunohistochemistry.
4. CTCL disease stage at study entry as follows, according to ISCL/EORTC (Olsen 2011).
- Lead-In Part: Stage IA - IV, except participants with CNS involvement.
- Main Study: Stage I - III
5. History of prior therapies for CTCL: must have had prior therapy, any number of prior
therapies allowed.
Topical treatments (except topical chemotherapy) and steroids are not considered as
prior therapies.
6. A minimum washout period of 4 weeks after previous CTCL therapy is recommended before
the first dose of E7777.
Participants must have recovered from any adverse effects from any previous CTCL
therapy to Common Terminology Criteria for Adverse Events (CTCAE) Grade <2 before
starting study drug. A shorter washout may be allowed if participant is experiencing
progressive disease despite ongoing treatment.
7. Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2 in the Lead-In
Part and performance status of 0 or 1 in the Main Study.
8. Life expectancy greater than or equal to 3 months in the Lead-In Part and greater than
or equal to 12 months in the Main Study.
9. Adequate bone marrow reserves as evidenced by:
- platelets greater than or equal to 100,000/mm^3 (100 x 10^9/L)
- clinically stable hemoglobin greater than or equal to 9 gram per deciliter (g/dL)
(90 g/L) and hematocrit greater than or equal to 27% without transfusion support
10. Normal hepatic function as evidenced by:
- bilirubin <= 1.5* upper limit if normal (ULN) and alkaline phosphatase <=3.0*ULN
- aspartate aminotransferase (AST) and alanine aminotransferase (ALT) <= 3.0*ULN
- albumin >= 3.0 g/dL (30 g/L)
11. Adequate renal function as evidenced by serum creatinine less than or equal to 1.8
mg/dL (158 umol/L) or calculated creatinine clearance greater than or equal to 50
mL/min (per the Cockcroft-Gault formula) with less than 2+ protein or 24- hour urine
creatinine clearance greater than or equal to 50 mL/minute with 24- hour urine protein
less than 1gram.
12. Provide written informed consent prior to any study-specific screening procedures.
13. Females may not be lactating or pregnant at Screening or Baseline
14. All females will be considered to be of childbearing potential unless they are
postmenopausal or have been sterilized surgically
15. Male participants must have had a successful vasectomy (confirmed azoospermia) or they
and their female partner must meet the criteria above
Exclusion Criteria
Participants who meet any of the following criteria will be excluded from the study:
1. Prior denileukin diftitox therapy
2. Use of topical steroids within 14 days of Day 1 of initial therapy is not
allowed.Topical steroids or systemic low dose steroids of less than or equal to 10
milligram per day (mg/day) prednisone are allowed in participants with erythroderma
who have been on corticosteroids for a prolonged period of time and where
discontinuation may lead to rebound flare in disease. The concomitant steroid
medication is allowed as long as the type of steroid, route of administration, and
steroid dose remain the same as what the participant had been receiving for a
prolonged period of time.
3. Active malignancy (except for CTCL, definitively treated basal or squamous cell
carcinoma of the skin, and carcinoma in-situ of the cervix) within the past 24 months.
4. Serious intercurrent illness
5. Significant cardiac disease requiring ongoing treatment, including congestive heart
failure (CHF), severe coronary artery disease (CAD), cardiomyopathy, uncontrolled
cardiac arrhythmia, unstable angina pectoris, or myocardial infarction (MI)
6. Significant pulmonary symptoms or disease
7. History of uncontrolled seizure disorder or active central nervous system disease
8. Major surgery within 2 weeks of study enrollment
9. Significant or uncontrolled infections requiring systemic anti-infective therapy
10. Known human immunodeficiency virus (HIV) infection; known active hepatitis B or
hepatitis C infection
11. Females who are pregnant (positive urine test) or breastfeeding
12. Any history of a medical condition or a concomitant medical condition that, in the
opinion of the investigator, would compromise the participant's ability to safely
complete the study.
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
Elle (Hyunjin) Kim
650-387-4436
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.