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 Dose Escalation and Cohort Expansion Study of NKTR-214 in Combination With Nivolumab and Other Anti-Cancer Therapies in Patients With Select Advanced Solid Tumors
In this four-part study, NKTR-214 was administered in combination with nivolumab and with/without other anticancer therapies. Part 1 considered escalating doublet (NKTR 214 + nivolumab) doses to determine the RP2D. Part 2 considered dose expansion cohorts for the doublet (NKTR 214 + nivolumab ± chemotherapy). Part 3 was schedule-finding for a triplet therapy (NKTR 214 + nivolumab + ipilimumab). Part 4 dose expansion for the triplet (NKTR 214 + nivolumab + ipilimumab) was planned to further assess the efficacy of the RP2D triplet combination at dosing schedules from Part 3.
Stanford is currently not accepting patients for this trial.
Stanford Investigator(s):
Intervention(s):
- drug: Dose Escalation Doublet: Combination of NKTR-214 + nivolumab
- drug: Dose Expansion Doublet: Combination of NKTR-214 + nivolumab
- drug: Schedule Finding Triplet: Combination of NKTR-214+ nivolumab+ ipilimumab
- drug: Dose Expansion Triplet: Combination of NKTR-214+ nivolumab+ ipilimumab
Eligibility
INCLUSION CRITERIA - For Parts 1-4:
- Histologically confirmed diagnosis of a locally advanced (not amenable to curative
therapy such as surgical resection) or metastatic solid tumors
- Life expectancy > 12 weeks
- Patients must not have received prior interleukin-2 (IL-2) therapy
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Measurable disease per RECIST 1.1
- Patients with stable brain metastases under certain criteria
- Fresh and archival tumor tissue available Tumor specific inclusion criteria may apply.
EXCLUSION CRITERIA - For Parts 1-4:
- Use of an investigational agent or an investigational device within 28 days before
administration of first dose of NKTR--214
- Females who are pregnant or breastfeeding
- Participants who have an active autoimmune disease requiring systemic treatment within
the past 3 months or have a documented history of clinically severe autoimmune disease
that requires systemic steroids or immunosuppressive agents
- History of organ transplant that requires use of immune suppressive agents
- Active malignancy not related to the current diagnosed malignancy
- Evidence of clinically significant interstitial lung disease or active, noninfectious
pneumonitis
- Participants who have had < 28 days since the last chemotherapy, biological therapy,
or < 14 days from approved tyrosine kinase inhibitor (TKI) therapy, or systemic or
inhaled steroid therapy at doses greater than 10mg of prednisone Tumor specific
exclusion criteria may apply.
Other protocol defined inclusion/exclusion criteria may apply
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
Brianna Velazquez
650-723-0270
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.