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 III Trial Evaluating Chemotherapy and Immunotherapy for Advanced Nasopharyngeal Carcinoma (NPC) Patients

This study is a multi-center, randomized, open label, Phase III clinical trial for advanced Nasopharyngeal Carcinoma(NPC) Patients.

Drugs used in chemotherapy, such as gemcitabine and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving an infusion of a person's cytotoxic T cells (CTL) that have been treated in the laboratory may help the body build an effective immune response to kill tumor cells. Giving combination chemotherapy together with laboratory-treated T cells may kill more tumor cells. This Phase III trial is to assess if combined gemcitabine-carboplatin (GC) followed by adoptive T-cell therapy would improve clinical outcome for patients with advanced nasopharyngeal carcinoma (NPC). It is also the world's first, and largest, Phase 3 T-cell therapy cancer trial ever conducted, and enrollment is ongoing for 330 patients from 30 hospital centers across Asia and the United States.

This clinical trial is conducted on the back of a successful Phase 2 NPC trial involving 38 patients at the National Cancer Centre, Singapore. This trial produced the best published 2-year (62.9%), and median overall survival (OS) data (29.9 months) in 35 patients with advanced NPC who received autologous EBV-specific CTL. Kindly see https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3978790/ for the Phase 2 publication titled "Adoptive T-cell Transfer and Chemotherapy in the First line treatment of Metastatic and/or Locally Recurrent Nasopharyngeal Carcinoma".

Stanford is currently not accepting patients for this trial.

Stanford Investigator(s):

Intervention(s):

  • drug: combination IV gemcitabine and IV carboplatin (AUC2)
  • biological: autologous EBV specific Cytotoxic T cells

Eligibility


Key Inclusion Criteria

   1. Metastatic or locally recurrent EBV-positive, non-keratinizing and/ or
   undifferentiated NPC* who do not have curative options such as chemo-radiation or
   surgery

   *Subjects will be enrolled based on confirmed histology diagnosis of the NPC

   2. Radiologically measurable disease as per RECIST 1.1

   3. Human Immunodeficiency Virus (HIV) negative*

   * Status of HIV must be confirmed via a HIV antibody test or other confirmatory tests
   available within 4 weeks of screening

   4. Bilirubin <2 x upper limit of normal (ULN) and aspartate aminotransferase (AST),
   alanine aminotransferase (ALT) <3 x ULN

   5. Calculated creatinine clearance (CRCL) ≥40 mL/min. Glomerular Filtration Rate (GFR) is
   calculated based on Cockcroft-Gault method.

   6. Normal corrected calcium levels

   7. Absolute neutrophil count >1200/mm3, hemoglobin (Hb) ≥10 g/dL and platelets
   ≥100,000/mm3

   8. Male or female

   9. Age ≥ 18 years or according to local legal age of consent

10. Eastern Cooperative Oncology Group Performance Scale (ECOG-PS) ≤2

11. Written informed consent

12. Life expectancy >6 months

Key Exclusion Criteria

   1. Severe concomitant illness i.e. chronic obstructive pulmonary disease (COPD), ischemic
   heart disease (IHD), active congestive cardiac failure (CCF), active angina pectoris,
   uncontrolled arrhythmia, uncontrolled hypertension

   2. HIV Positive*

   * Status of HIV must be confirmed via a HIV antibody test or other confirmatory tests
   available within 4 weeks of screening

   3. Pregnant or lactating females

   4. Refuse of use of contraception during trial (both male and female patients)

   5. Investigational therapy less than one month prior to study entry

   6. Pre-existing peripheral neuropathy (National Cancer Institute Common Terminology
   Criteria for Adverse Events [NCI CTCAE] ≥2)

   7. Central nervous system metastasis

   8. Previous or concurrent cancer that is distinct in primary site or histology from the
   cancer being evaluated in this study, EXCEPT cervical carcinoma in situ, treated basal
   cell carcinoma, superficial bladder tumors [Ta, Tis and T1] or any cancer curatively
   treated >3 years prior to study entry

   9. Positive hepatitis B surface antigen (HBsAg) results

10. Known history of hepatitis C and recovery status has not been determined at time of
   screening

11. Prior anti-cancer treatment for metastatic or locally recurrent disease, EXCEPT:

   For metastatic or locally recurrent disease, localised palliative radiotherapy is
   allowed.

   For locally recurrent disease, the following treatment is allowed

      - Prior radiotherapy with curative intent

      - Prior chemo-radiotherapy with curative intent

      - Adjuvant chemotherapy

      - Localised palliative radiotherapy Prior chemotherapy must be > 6 months before
      screening

12. Severe intercurrent infections

13. Prior immunotherapy for metastatic or locally recurrent disease

The following is allowable:

• Adjuvant immunotherapy/ biologics Prior adjuvant immunotherapy/ biologics must be > 6
months before screening

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
Elizabeth Winters
650-721-6509
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.