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.
An Escalating Dose Tolerance Trial of BG8962 (rCD4) in Patients Who Are HIV Antibody Positive
To determine the maximal safe daily dose of BG8962 (rCD4) which can be administered by continuous subcutaneous infusion (CSCI) over 24 hours; to determine the pharmacokinetics of BG8962 when it is administered by intramuscular and subcutaneous routes; and to look for dose related antiviral activity determined by quantitation of infectious HIV peripheral blood leukocytes (PBLs) and plasma, and by monitoring the blood levels of viral p24 antigen (when present), CD4+ T-cells, and Beta-2- microglobulin. Recombinant soluble CD4 protein (rCD4) is a drug that has been produced by genetic engineering techniques. In laboratory studies, rCD4 binds to HIV and reduces its ability to enter the cell, thus inhibiting its reproduction. Before rCD4 can be tested for therapeutic effectiveness in HIV-infected patients, it is necessary to determine the maximum dose that can be tolerated by humans. AMENDED: To date, Biogen's original sequence recombinant soluble CD4 and Biogen's natural sequence recombinant soluble CD4 have both been referred to as recombinant soluble CD4 (rsCD4). In order to distinguish between these two products, a change in nomenclature has been made. In this protocol, whenever the original sequence CD4 molecule is referred to, it is called recombinant soluble T4 (rsT4). Whenever the natural sequence molecule (currently under study in this protocol) is referred to, it is called BG8962 or rCD4. Whenever the drug is discussed generically, it is referred to as rsCD4.
Stanford is currently not accepting patients for this trial.
Stanford Investigator(s):
Intervention(s):
- drug: CD4 Antigens
Eligibility
Inclusion Criteria
Concurrent Medication:
Allowed:
- Nystatin or clotrimazole for suppression of oral thrush.
- Aerosolized pentamidine for Pneumocystis prophylaxis in Group A patients.
- Trimethoprim / sulfamethoxazole for Pneumocystis prophylaxis in patients who are
hematologically stable on trimethoprim / sulfamethoxazole.
Patients must have:
- Group A: AIDS and symptoms defined in disease status.
- Group B: AIDS related complex (ARC) and symptoms defined in disease status.
Exclusion Criteria
Co-existing Condition:
Patients with the following disease or conditions are excluded:
- Malignancies other than Kaposi's sarcoma.
- AIDS dementia.
- Opportunistic infections requiring ongoing therapy except oral thrush suppression with
nystatin or clotrimazole or Pneumocystis prophylaxis in Group A patients.
- Significant organ system dysfunction including:
- Granulocytopenia with a granulocyte count < 1000 cells/mm3.
- Thrombocytopenia - < 75000 platelets/mm3.
- Anemia with a hemoglobin < 9.5 g/dl.
- Renal dysfunction - creatinine > 2 mg/dl.
- Hepatic dysfunction with enzymes or bilirubin > 3 x upper limit of normal.
Patients with the following are excluded:
- Preexisting antibodies to rCD4.
- Malignancies other than Kaposi's sarcoma.
- AIDS-dementia complex.
- Opportunistic infections requiring ongoing therapy.
- Significant organ system dysfunction.
- Inability to sign voluntarily the consent form.
Prior Medication:
Excluded:
- Recombinant soluble CD4 protein (rCD4).
- Excluded within 30 days of study entry:
- Immunomodulatory therapy or agent with anti-HIV activity.
- Chemotherapy.
Prior Treatment:
Excluded within 30 days of study entry:
- Radiotherapy.
Active illicit drug use or alcohol abuse at time of entry.
Ages Eligible for Study
13 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
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.