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.
Phase I Bortezomib (VELCADE) in Combo With Pralatrexate in Relapsed/Refractory MM
The purpose of this trial is to find out the maximum tolerated dose (MTD) of bortezomib (VELCADE) in combination with pralatrexate in patients with previously treated multiple myeloma, AL amyloid and Waldenstroem's macroglobulinemia.
Stanford is currently not accepting patients for this trial.
Stanford Investigator(s):
Intervention(s):
- drug: velcade
- drug: Pralatrexate
Eligibility
Inclusion Criteria:
- The patient has relapsed or refractory multiple myeloma that has progressed following
at least on prior therapy.
- Relapsed myeloma is defined in patients as at least 25% increasing monoclonal
(M)-protein in serum or urine or in the size of a plasmacytoma compared to a best
response reached after previous therapy.
- Refractory myeloma is defined as failure to achieve at least a minor response (patient
achieved stable disease as his/her best response) or progression of disease on current
therapy or within 60 days of last dose of current therapy.
- The patient has measurable disease defined as one of the following:
1. serum M-protein >=1 g/dL
2. urine M-protein >=200 mg/24 hours
- Must have received at least one (1) prior line of systemic treatment that may have
included VELCADE.
a. NOTE: Patients may have undergone prior allogeneic or autologous stem cell
transplantation (stem cell transplant with high dose induction chemotherapy
with/without planned maintenance therapy will be considered one line of therapy).
- No cytotoxic chemotherapy within 4 weeks prior to registration for protocol therapy.
a. NOTE: this interval may be reduced to 14 days for thalidomide, lenalidomide,
VELCADE or corticosteroids, provided other entry criteria are met.
- No concurrent steroid use in doses greater than 10 mg daily of Prednisone (or
equivalent) if given for management of co-morbid conditions.
- Age >= 18 at the time of consent.
- The patient has a life expectancy of more than 3 months.
- No known central nervous system involvement by myeloma.
- ECOG performance status 0-2.
- No poorly controlled intercurrent illness including, but not limited to, ongoing or
active infection, poorly controlled diabetes, symptomatic congestive heart failure, or
psychiatric illness that in the opinion of the investigator would limit compliance
with study requirements.
- Patients must have adequate bone marrow function: Platelets >100 x 109/L, Hemoglobin >
8.0g/dL and ANC > 1 x 109/L
- Patients must have adequate liver functions: AST and ALT < 2.5 X upper limit of
normal, Total bilirubin <= 1.5 x ULN
- Patients must have adequate renal function defined as creatinine clearance of 30
ml/minute (Cockcroft-Gault).
- The patient must have been on a regimen of 1.0 - 1.25 mg PO QD of folic acid for at
least 10 days prior to the planned start of pralatrexate and received 1 mg IM of
vitamin B12 within 10 weeks of the planned start of pralatrexate.
- Patients with reproductive potential must use an effective method of contraception to
avoid pregnancy for the duration of the trial.
- If female of childbearing potential, pregnancy test must be negative within 7 days
prior to registration for protocol therapy.
- Ability to understand and the willingness to sign a written informed consent document
including HIPAA authorization for release of personal health information.
- The patient must be willing and able to receive outpatient treatment and laboratory
monitoring at the Stanford Cancer Center.
Exclusion Criteria:
- The patient has nonmeasurable multiple myeloma, defined as less than 1g/dl M-protein
in serum and less than 200 mg/24 hours M-protein in urine.
- The patient received glucocorticoid therapy (prednisone > 10 mg/day orally or
equivalent) within the last 2 weeks prior to the first dose of study drug.
- The patient received chemotherapy with approved or investigative anticancer
therapeutics within 4 weeks.
a. NOTE: this interval may be reduced to 14 days for thalidomide, lenalidomide,
VELCADE or corticosteroids, provided other entry criteria are met.
- The patient has an acute infection requiring systemic antibiotics, antiviral agents,
or antifungal agents within 2 weeks before the first dose of study drug.
- The patient has grade 2 or higher neuropathy within 14 days of enrollment.
- The patient has any serious psychiatric or medical condition that could interfere with
treatment and study procedures, place the patient at unacceptable risk, or confound
the ability of investigators to interpret study data.
- The patient is a pregnant or lactating woman.
- Myocardial infarction within 6 months prior to enrollment or has New York Heart
Association (NYHA) Class III or IV heart failure (see Appendix A), uncontrolled
angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence
of acute ischemia or active conduction system abnormalities. Prior to study entry, any
ECG abnormality at Screening has to be documented by the Investigator as not medically
relevant.
- Patient has hypersensitivity to VELCADE, boron or mannitol.
- Diagnosed or treated for another malignancy within 3 years of enrollment, with the
exception of complete resection of basal cell carcinoma or squamous cell carcinoma of
the skin, an in situ malignancy, or low-risk prostate cancer after curative therapy.
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
ccto-office@stanford.edu
650-498-7061
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.