Stanford APBI Trial
Clinical Trial
Overview
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.
Efficacy and Safety Study of Apremilast (CC-10004) in Pediatric Subjects From 6 Through 17 Years of Age With Moderate to Severe Plaque Psoriasis
This is a Phase 3, multicenter, randomized, placebo-controlled, double-blind study of the efficacy and safety of apremilast (CC-10004) in pediatric subjects with moderate to severe plaque psoriasis.
At least 230 pediatric subjects (ages 6 through 17 years) will be randomized 2:1 to receive either apremilast or placebo for the first 16 weeks and then all subjects will receive apremilast during the 36 week Extension Phase for a total of 52 weeks. Randomization to apremilast arm or placebo arm will be stratified by age group (6 to 11 years or 12 to 17 years). Subjects will receive apremilast treatment of either 20 mg twice daily (BID) or 30 mg BID, depending on weight. This Phase 3 study is being conducted to evaluate the safety and efficacy of apremilast in the treatment of pediatric subjects.
Stanford is currently not accepting patients for this trial.
Stanford Investigator(s):
Intervention(s):
- drug: Apremilast (CC-10004)
- other: Placebo
Eligibility
Inclusion Criteria:
1. Males or female subjects 6 to 17 years of age, inclusive, at the time the informed
consent form is signed by the legal guardian
2. Subjects must have a weight of ≥ 20 kg
3. Diagnosis of chronic plaque psoriasis for at least 6 months prior to Screening.
4. Has moderate to severe plaque psoriasis at Screening and Baseline as defined by:
- PASI score ≥ 12; and
- Body surface area (BSA) ≥ 10%; and
- sPGA ≥ 3 (moderate to severe)
5. Disease inadequately controlled by or inappropriate for topical therapy for psoriasis
6. Candidate for systemic therapy or phototherapy
Exclusion Criteria:
1. Guttate, erythrodermic, or pustular psoriasis at Screening and Baseline
2. Psoriasis flare or rebound within 4 weeks prior to Screening
3. Prior history of suicide attempt at any time in the subject's lifetime prior to
Screening or randomization in the study, or major psychiatric illness requiring
hospitalization within 3 years prior to signing the assent and informed consent
4. Answer "Yes" to any question on the Columbia-Suicide Severity Rating Scale during
Screening or at Baseline
5. Current or planned concurrent use of the following therapies that may have a possible
effect on psoriasis
a. Topical therapy within 2 weeks prior to randomization (including but not limited to
topical corticosteroids, topical retinoid or vitamin D analog preparations,
tacrolimus, pimecrolimus, or anthralin/dithranol)
Exceptions*:
i. Low potency or weak corticosteroids (please refer to the Investigators' Manual)
will be allowed as background therapy for treatment of the face, axillae and groin in
accordance with manufacturer's suggested usage ii. Unmedicated skin moisturizer (eg,
Eucerin®) will also be permitted for body lesions
*Subjects should not use these topical treatments within 24 hours prior to the clinic
visit.
b. Conventional systemic therapy for psoriasis within 4 weeks prior to randomization
c. Phototherapy treatment (ie, ultraviolet B [UVB], PUVA) within 4 weeks prior to
randomization d. Biologic therapy within 4 weeks prior to randomization or 5 PK/PD
half-lives (whichever is longer).
Ages Eligible for Study
6 Years - 17 Years
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
Research Team @ Pediatric Dermatology
650-724-1982
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.