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 of ONTAK and CHOP in Newly Diagnosed, Peripheral T-Cell Lymphoma
Study of ONTAK and CHOP (chemotherapy drugs) to find out their ability to make Peripheral T-cell lymphoma disappear (for any period of time) and potentially lengthen life. The study will also compare what kind of side effects these drugs cause and how often they occur. The hypothesis is that patients with newly diagnosed peripheral T-Cell lymphoma, when given ONTAK + CHOP, will tolerate the treatment and will have a 20% improvement in response rate when compared to CHOP alone.
Stanford is currently not accepting patients for this trial.
Stanford Investigator(s):
Intervention(s):
- drug: Denileukin diftitox
- drug: Cyclophosphamide
- drug: Doxorubicin
- drug: Vincristine
- drug: Prednisone
- other: Pegfilgrastim
Eligibility
Inclusion Criteria:
- Pathological diagnosis of peripheral T-cell lymphoma of one of the following
histologies as per the REAL classification: peripheral T-cell lymphoma (unspecified),
anaplastic large cell lymphoma CD30+, angioimmunoblastic T-cell lymphoma, nasal/nasal
type T/NK cell lymphoma, intestinal T-cell lymphoma, hepatosplenic T-cell lymphoma,
subcutaneous panniculitic T-cell lymphoma.
- Treatment naïve except for prior radiation or a single cycle of CHOP.
- Patients must have at least one clear-cut bidimensionally measurable site by physical
exam and/or computed tomography.
- Prior radiation therapy for localized disease is allowed as long as the irradiated
area is not at the mediastinal area or at the only site of measurable disease. Therapy
must be completed at least 4 weeks before the enrollment in study.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
- At least 18 years of age.
- Adequate bone marrow reserve, indicated by absolute neutrophil count (ANC) > or equal
to 1000/microL, platelets > or equal to 50,000/microL (25,000/MicroL if
thrombocytopenia secondary to bone marrow involvement by lymphoma), and hemoglobin >
or equal to 8 g/dL.
- Adequate liver function, indicated by bilirubin < or equal to 1.5 times the upper
limit of normal (ULN), alanine transaminase (ALT) < or equal to 2 times the ULN or
aspartate transaminase (AST) < or equal to 2.0 times the ULN, and albumin > or equal
to 3.0 g/dL.
- Adequate renal function, indicated by serum creatinine < or equal to 2.5 mg/dL.
- Women of childbearing potential and sexually active males agree to use an accepted and
effective method of contraception.
- Able to give informed consent.
Exclusion Criteria:
- Diagnosis of Mycosis Fungoides or Sezary Syndrome.
- Active Hepatitis B or Hepatitis C infection.
- Known HIV infection (HIV testing is not required).
- Patients with active infections requiring specific anti-infective therapy are not
eligible until all signs of infections have resolved and any continuing treatment if
appropriate is given on an outpatient basis.
- Previous doxorubicin therapy with cumulative dose of >100 mg/m2.
- Left Ventricular Ejection Fraction (LVEF) < 50%.
- Patients who are pregnant or breast-feeding.
- Prior invasive malignancies within past 5 years.
- Allergy to or history of allergy to diphtheria toxin or IL-2.
- Preexisting severe cardiovascular disease (e.g. CHF, Severe CAD, cardiomyopathy, MI
within the past 3 months, arrhythmia) requiring ongoing treatment.
- Ongoing antineoplastic chemotherapy, radiation, hormonal (excluding contraceptives) or
immunotherapy, or investigational medications within past 30 days.
- Patients with deep vein thrombosis within 3 months.
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
Sipra Choudhury
6507362563
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.