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 Trial of PF-07901800 (TTI-621) for Patients With Hematologic Malignancies and Selected Solid Tumors
Multicenter, open-label, phase 1a/1b trial of PF-07901800 (TTI-621) in subjects with relapsed or refractory hematologic malignancies and selected solid tumors.
Stanford is currently not accepting patients for this trial.
Stanford Investigator(s):
Intervention(s):
- drug: PF-0791800 (TTI-621)
- drug: PF-07901800 (TTI-621) plus Rituximab
- drug: PF-07901800 (TTI-621) plus Nivolumab
Eligibility
MAJOR ELIGIBILITY CRITERIA:
Phase 1a Escalation
• Histologically documented, measurable, advanced lymphomas, transfusion-independence
Phase 1b Expansion (Part 2 and 3) • Advanced malignancy: IBCL, ABCL, cHL, AML, ALL, MDS,
MPN, SCLC, PTCL and CTCL; measurable disease who have relapsed or are refractory following
at least 2 prior systemic therapeutic attempts (1 prior systemic attempt for PTCL). For
CTCL, extracorporeal photochemotherapy (ECP) considered a systemic therapy. Local radiation
and topical agents are not systemic therapies.
Phase 1b dose optimization (Part 4)
• Histologically confirmed diagnosis of CTCL (both Mycosis Fungoides and Sezary Syndrome):
Failed at least 2 prior systemic therapies for CTCL (Systemic therapy does not include
local radiation therapy or topical agents); History of histologically documented diagnosis
of CTCL stage IB to IVB
Inclusion Criteria (all subjects):
- Advanced measurable malignancy with previously progressed on, or currently progressing
on standard anticancer therapy or for whom no other approved conventional therapy
exists
- Eastern Cooperative Oncology Group (ECOG) 0-2
- Adequate hematologic, hepatic, renal, and coagulation function; fresh or archived
tumor tissue available for immunohistochemistry
- Recovery from prior treatments and/or surgeries; no history of hemolytic anemia or
bleeding diathesis.
- AML M3 (French American British, FAB, classification) (i.e., acute promyelocytic
leukemia [APL]) excluded
Exclusion Criteria:
- Known current central nervous system disease involvement or untreated brain metastases
- Allogeneic transplant within 30 days prior to the planned start of treatment or
subjects with active graft-vs-host disease with the exception of Grade 1 skin
involvement
- History of hemolytic anemia or bleeding diathesis
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.