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 Mipasetamab Uzoptirine (ADCT-601) in Participants With Solid Tumors

The primary objective of this study is to identify the recommended phase 2 dose (RP2D) and/or the maximum tolerated dose (MTD), and characterize the safety and tolerability of ADCT-601 monotherapy and in combination with gemcitabine.

Stanford is currently accepting patients for this trial.

Intervention(s):

  • drug: ADCT-601
  • drug: Gemcitabine

Eligibility


Inclusion Criteria:

   1. Male or female participant aged 18 years or older.

   2. Pathologic diagnosis of solid tumor malignancy that is locally advanced or metastatic
   at time of screening:

   Part 1:

      1. Combination therapy arms: Selected sarcoma indications from the following 2
      separate categories.

         - Soft tissue sarcoma: leiomyosarcoma, liposarcoma, undifferentiated
         pleomorphic sarcoma (UPS; covering malignant fibrous histiocytoma) and
         synovial sarcoma.

         - Bone sarcoma: Ewing's sarcoma (including extraskeletal), osteosarcoma, and
         chondrosarcoma.

      2. Monotherapy arms:

         - Sarcoma indications (including those listed for combination therapy arms)
         regardless of AXL gene amplification status.

         - NSCLC regardless of AXL gene amplification status.

         - Solid tumors (lymphomas participants are excluded) with known AXL gene
         amplification.

   Part 2:

      1. Combination therapy arms: Sarcoma indications and PAAD.

      2. Monotherapy arms: PAAD, NSCLC and solid tumors with AXL expression.

   3. Participants who are refractory to or intolerant to available standard therapy(ies)
   known to provide clinical benefit for their condition per Investigator judgment.

   4. Participants with measurable disease as determined by Response Evaluation Criteria in
   Solid Tumors (RECIST) v1.1.

   5. Eastern Cooperative Oncology Group (ECOG) performance status 0 - 1.

   6. PAAD only: Royal Marsden Hospital Prognostic Score 0 - 1.

Exclusion Criteria:

   1. History of recent infection requiring intravenous (IV) antibiotics, IV antiviral, or
   IV antifungal treatment within 4 weeks of Cycle 1 Day 1 (C1D1).

   2. Symptomatic central nervous system (CNS) metastases or evidence of leptomeningeal
   disease (brain magnetic resonance imaging [MRI] or previously documented cerebrospinal
   fluid [CSF] cytology). Previously treated asymptomatic CNS metastases are permitted
   provided that the last treatment (systemic anticancer therapy and/or local
   radiotherapy) was completed ≥4 weeks prior to Day 1 except usage of low dose of
   steroids on a taper (i.e., up to 10 mg prednisone or equivalent on Day 1 and
   consecutive days is permissible if being tapered down). Participants with discrete
   dural metastases are eligible.

   3. Clinically significant third space fluid accumulation (i.e., ascites requiring
   drainage or any serosal effusion that is either requiring drainage or associated with
   shortness of breath).

   4. Active diarrhea Common Terminology Criteria for Adverse Events (CTCAE) Grade 2 or a
   medical condition associated with chronic diarrhea (such as irritable bowel syndrome,
   inflammatory bowel disease).

   5. Use of any other experimental medication within 14 days prior to start of study drug
   (C1D1).

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Now accepting new patients

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Feriel Buchholz
650-721-4090
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.