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 Phase 2 Study of Ruxolitinib With Chemotherapy in Children With Acute Lymphoblastic Leukemia
This is a nonrandomized study of ruxolitinib in combination with a standard multi-agent chemotherapy regimen for the treatment of B-cell acute lymphoblastic leukemia. Part 1 of the study will optimize the dose of study drug (ruxolitinib) in combination with the chemotherapy regimen. Part 2 will evaluate the efficacy of combination chemotherapy and ruxolitinib at the recommended dose determined in Part 1.
Stanford is currently accepting patients for this trial.
Stanford Investigator(s):
Intervention(s):
- drug: Ruxolitinib
- drug: Asparaginase Erwinia Chrysanthemi
- drug: Cyclophosphamide
- drug: Cytarabine
- drug: Dexamethasone
- drug: Doxorubicin
- drug: Leucovorin Calcium
- drug: Mercaptopurine
- drug: Methotrexate
- drug: Pegaspargase
- drug: Prednisone
- drug: Thioguanine
- drug: Vincristine Sulfate
Eligibility
Inclusion Criteria:
- Eligible for study when participant is 1 year to 21 years at the time of diagnosis
- Eligible Ages in Canada; 2 years to 21 years
- De novo high-risk (HR) Ph-like B-ALL for which any of following criteria are present
at diagnosis:
- Age ≥ 10 years
- White blood cell (WBC) ≥ 50 × 10^3/μL
- CNS3 leukemia at diagnosis
- Systemic steroid pretreatment without presteroid WBC documentation
- Diagnostic bone marrow or peripheral blood sample must have gene expression profiling
and downstream genetic testing performed by submitting diagnostic specimens under the
COG AALL08B1 or APEC14B1 biology studies, or AALL1131 or its successor study.
Specimens must demonstrate a Ph-like expression profile (ie, LDA-positive) as tested
by low density microarray testing at the COG ALL reference laboratory or TriCore
laboratory at the University of New Mexico AND must contain 1 of the following genetic
lesions: (determined at COG ALL reference laboratories, or equivalent
CAP/CLIA-certified laboratories approved by the medical monitor:
1. CRLF2 rearrangement with confirmed JAK1 or JAK2 mutation (JAK+)
2. CRLF2 rearrangement without JAK mutation
3. Other JAK pathway alterations (eg, JAK2 fusions, EPOR fusions, SH2B3 deletions,
IL7RA mutations) with or without CRLF2-R, or CRLF2-R with unknown JAK status as
determined by a COG ALL Reference Laboratory
- Completed a 4-drug Induction therapy regimen (modified aBFM regimen or equivalent) in
Study AALL1131 or its successor study, or as per the institutional standard of care
for HR B-ALL and have had end-Induction minimal residual disease (MRD) assessed
- Male and female subjects of reproductive non childbearing potential or willing to take
appropriate precautions to avoid pregnancy or fathering a child for the duration of
study participation
Exclusion Criteria:
- Receipt of any other cytotoxic chemotherapy before Induction therapy, with exception
of hydroxyurea or steroid pretreatment
- Trisomy 21 (Down syndrome)
- BCR-ABL1-rearranged (Ph+) ALL
- Calculated creatinine clearance or radioisotope glomerular filtration rate < 70
mL/min/1.73 m^2
- Alanine aminotransferase ≥ 5 × upper limit of normal (ULN) for age
- Direct bilirubin ≥ 1.5 × ULN (may be assumed if total bilirubin is below ULN)
- History or evidence of cirrhosis
- Platelet count < 75 × 10^3/μL
- Absolute neutrophil count (ANC) < 750/μL
- Positive screen for hepatitis B or C
- Known human immunodeficiency virus infection
Ages Eligible for Study
1 Year - 21 Years
Genders Eligible for Study
All
Now accepting new patients
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Zeel Patel
650-736-2563
I'm interested
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.