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.

Phase 1/2 Study of X-396, an Oral ALK Inhibitor, in Patients With ALK-positive Non-Small Cell Lung Cancer

This is the first human study to use X-396 (ensartinib), a drug being developed for treatment of advanced cancers. The initial purpose of the study is to determine the largest amount of X-396 that can be safely given to humans (the maximum tolerated dose). Once the recommended Phase 2 dose has been determined, an expansion phase will assess the preliminary anti-tumor activity of X-396 in ALK-positive non-small cell lung cancer. The study will also provide early information on how the body handles the drug (pharmacokinetics) and on the efficacy of X-396.

Stanford is currently not accepting patients for this trial.

Intervention(s):

  • drug: Phase I: X-396 (ensartinib)
  • drug: Phase II: X-396 (ensartinib)

Eligibility


Inclusion Criteria:

   1. Histologically or cytologically confirmed diagnosis of advanced solid tumor
   malignancy. Patients may be ALK TKI-naive or may have received prior crizotinib and/or
   second generation ALK TKIs. In addition, patients with a known ALK 1198 mutation will
   be allowed.

   -For the expanded cohort portion of the study, patients must have NSCLC with ALK
   genomic alterations; however, patients will be allowed to enroll based on local
   FDA-approved ALK results.

   2. Eastern Cooperative Group ECOG) Performance Status score of 0 or 1.

   3. Ability to swallow and retain oral medication.

   4. Adequate organ system function.

   5. Patients with treated or untreated asymptomatic CNS metastases may be allowed to
   enroll.

   6. Male patients willing to use adequate contraceptive measures.

   7. Female patients who are not of child-bearing potential, and female patients of
   child-bearing potential who agree to use adequate contraceptive measures.

   8. Patients must be ≥ 18 years of age.

   9. Patients must have measurable or evaluable disease for the dose escalation portion of
   the study and measurable disease for the expanded cohort portion of the study (except
   for patients in the CNS metastases and leptomeningeal cohorts).

10. Willingness and ability to comply with the trial and follow-up procedures.

11. Ability to understand the nature of this trial and give written informed consent.

Exclusion Criteria:

   1. Patients currently receiving cancer therapy.

   2. Use of an investigational drug within 21 days or 5 half-lives (whichever is shorter)
   prior to the first dose of X-396. A minimum of 10 days between treatment and X-396 and
   2 days between ALK TKI and X-396.

   3. Any major surgery, radiotherapy, or immunotherapy within the last 21 days (focal
   radiation does not require a washout period; ≥4 weeks for WBRT). Chemotherapy regimens
   with delayed toxicity within the last 4 weeks. Chemotherapy regimens given
   continuously or on a weekly basis with limited potential for delayed toxicity within
   the last 2 weeks.

   4. Prior stem cell transplant.

   5. Patients with a known allergy or delayed hypersensitivity reaction to drugs chemically
   related to X-396 (e.g., crizotinib) or to the active ingredient of X-396.

   6. Patients with primary CNS tumors are ineligible.

   7. Patients receiving CYP3A substrates with narrow therapeutic indices, strong CYP3A
   inhibitors, and strong CYP3A inducers.

   8. Concomitant use of herbal medications at least 7 days prior to the first dose of study
   drug and throughout participation in the trial.

   9. Females who are pregnant or breastfeeding.

10. Presence of active gastrointestinal (GI) disease or other condition that will
   interfere significantly with the absorption, distribution, metabolism, or excretion of
   X-396.

11. Clinically significant cardiovascular disease.

12. Patients who are immunosuppressed (including known HIV infection), have a serious
   active infection at the time of treatment, have known hepatitis C, or have any serious
   underlying medical condition that would impair the ability of the patient to receive
   protocol treatment.

13. Psychological, familial, sociological, or geographical conditions that do not permit
   compliance with the protocol.

14. Concurrent condition that in the investigator's opinion would jeopardize compliance
   with the protocol or would impart excessive risk associated with study participation
   that would make it inappropriate for the patient to be enrolled.

15. Inability or unwillingness to comply with study and/or follow-up procedures outlined
   in the protocol.

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
Danielle Pancirer
650-723-6498
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.