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 Zidovudine in HIV-Infected Patients Who Have Hemophilia
Study A: To determine whether treatment with zidovudine (ZDV) will delay or change the disease process in hemophilic patients who have HIV infection with no symptoms. The major clinical question is whether patients who receive chronic ZDV therapy will have a delay in the development of AIDS or AIDS-related complex (ARC). The pharmacokinetics (blood levels) of ZDV in hemophilic patients will also be studied.
Study B: To determine if ZDV therapy changes the risk of a hemophiliac transmitting HIV to his wife or other female sexual partner. To determine the effectiveness of counseling and education on the behaviors of the wives that place them at risk for HIV infection. To determine if antibodies to HIV either appear or disappear from the blood of any of the wives during the study.
Study A: Individuals who are infected with HIV can benefit from therapy with an effective anti-AIDS virus agent. ZDV is a potent inhibitor of HIV in vitro (test tube) and is safe in humans at the dose planned. It may be effective in preventing the development of AIDS or ARC in hemophiliacs who have the HIV antibody in their blood. The pharmacokinetic studies are especially important because the high prevalence of hepatic disease in this population may affect the metabolism and blood levels of ZDV.
Study B: HIV is transmitted by sexual contact, and wives of infected hemophilic patients have become infected during long-term sexual relationships. Transmission of the virus does not occur during casual family contact. This study will aid in determining if therapy influences the transmission of HIV, because the wives of hemophiliacs generally have no risk for HIV infection other than sexual contact with their spouse.
Stanford is currently not accepting patients for this trial.
Stanford Investigator(s):
Intervention(s):
- drug: Zidovudine
Eligibility
Inclusion Criteria
Concurrent Medication:
Allowed with caution for Study A:
- Hepatotoxic drugs.
Patients in Study A must have:
- Hemophilia with no symptoms for AIDS. Most patients will have well-established factor
8 or 9 deficiency. However, patients with other coagulation diseases, such as factor 5
deficiency, and von Willebrand disease, will also be acceptable for the study.
Wives in Study B are included even if they are known to be seropositive or are not sexually
active at the time the study starts.
Prior Medication:
Allowed for Study A:
- Patients who were on the Phase I ZDV study, ACTG 017, or are on ACTG 062 may enter
after waiting 3 weeks.
Exclusion Criteria
Co-existing Condition:
Patients in Study A with the following symptoms or conditions are excluded:
- AIDS-defining illness.
- Severe ARC.
- Severe or prolonged toxicity.
Concurrent Medication:
Excluded for Study A:
- Isoniazid or rifampin.
- Treatment for Pneumocystis carinii pneumonia (PCP), oral candidiasis, and localized
cutaneous herpes simplex or zoster infections.
- Probenecid.
- Aspirin on a regular basis, or for more than 72 hours without contacting the
investigator.
- Drugs causing neutropenia or significant risk of nephrotoxicity.
Patients in Study A with the following prior conditions are excluded:
- AIDS-defining opportunistic infection or malignancy.
- Unexplained temperature greater than 38 C for more than 5 consecutive days or more
than 10 days in any 30-day period in the 2 years prior to entry.
- Unexplained diarrhea defined as three or more liquid stools per day, persisting more
than 7 days within 2 years prior to entry.
- Unintentional weight loss of greater than 10 lbs. or more than 10 percent of usual
body weight within 2 years prior to study entry.
- Oral hairy leukoplakia at any time prior to entry.
- Oral candidiasis unrelated to the use of antibiotic therapy for more than 2 weeks
within 2 years prior to entry or within the past 3 months.
- Herpes zoster within 2 years prior to entry into the study.
Prior Medication:
Excluded for Study A:
- Antiretroviral agents, including ZDV, ribavirin, HPA-23, rifampin, AL721 within 8
weeks of study entry.
- Significant course of immunomodulating agents such as steroids (greater than 1 week),
isoprinosine, thymic factors within 3 months of study entry.
- Any other experimental therapy within 3 months of study entry.
Discouraged but not forbidden for Study B:
- Sexual contact with infected husband.
Ages Eligible for Study
12 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.