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.
Use of T-allo10 in Hematopoietic Stem Cell Transplantation (HSCT) for Blood Disorders
A significant number of patients with hematologic malignancies need a hematopoietic stem cell transplant (HSCT) to be cured. Only about 50% of these patients have a fully matched donor, the remaining patients will require an HSCT from a mismatched related or unrelated donor. Almost 60% of these mismatched donor HSCTs will result in graft-versus-host disease (GvHD), which can cause significant morbidity and increased non-relapse mortality. GvHD is caused by the donor effector T cells present in the HSC graft that recognize and react against the mismatched patient's tissues.
Researchers and physicians at Lucile Packard Children's Hospital, Stanford are working to prevent GvHD after HSCT with a new clinical trial. The objective of this clinical program is to develop a cell therapy to prevent GvHD and induce graft tolerance in patients receiving mismatched unmanipulated donor HSCT. The cell therapy consists of a cell preparation from the same donor of the HSCT (T-allo10) containing T regulatory type 1 (Tr1) cells able to suppress allogenic (host-specific) responses, thus decreasing the incidence of GvHD.
This is the first trial of its kind in pediatric patients and is only available at Lucile Packard Children's Hospital, Stanford.
The purpose of this phase 1 study is to determine the safety and tolerability of a cell therapy, T-allo10, to prevent GvHD in patients receiving mismatched related or mismatched unrelated unmanipulated donor HSCT for hematologic malignancies.
Stanford is currently not accepting patients for this trial.
Stanford Investigator(s):
Intervention(s):
- biological: T-allo10
Eligibility
Inclusion Criteria:
1. Eligible diseases include:
A. Acute Lymphoblastic Leukemia (B- or T-ALL)
1. Complete Response (CR)1-ultra high risk features
- Unfavorable cytogenetics
- Hypodiploidy
- Induction failure
- Minimal Residual Disease (MRD) positive after consolidation
2. CR-2:
- Any of the high risk features listed in CR1
- B-ALL: any relapse considered eligible for transplant
- T- ALL
3. CR-3-any
B. Acute Myeloid Leukemia
1. MRD >5% at day 22 induction 1
2. MRD >0.1% after induction 2
3. FLT/ITD with allelic ratio > 0.4 and MRD >0.1% at day 22 or 29 induction 1
4. Translocation (6:9), (8:6), (16:21), monosomy 7, monosomy 5, 5q
5. M7 with KMT2A rearrangements, inv(16)(p13.3q24.3) [CBFA2T3-GLIS2] or
t(11;12)(p15;p13) [NUP98-KDM5A]
6. AML in 2nd or subsequent CR
7. Therapy related or Secondary AML
8. Refractory anemia with excess blasts (RAEB)2
C. Myelodysplastic syndrome D. Mixed Phenotype Acute Leukemia MRD>1% after
consolidation E. Non-Hodgkin's lymphoma (NHL) or Hodgkin's lymphoma (HL) beyond first
remission
2. Age ≥3 to ≤45 years old. Subjects 1 and 2 (in Cohort 1) will be ≥ 12 years old
3. Available mismatched related donor (mMRD) or mismatched unrelated donor (mMUD), Human
leukocyte antigen (HLA) matched 8/10 or 9/10
4. Lansky (age <16) or Karnofsky (age ≥16) performance status ≥80%
5. Able and willing to provide written, signed informed consent (assent as appropriate)
6. Have adequate organ function defined as the following:
- Serum Creatinine <1.5 X upper limit of normal (ULN) or 24-hour creatinine
clearance >50 ml/min
- Serum bilirubin ≤ 2 x ULN
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST)
≤10 x ULN
- Diffusion Capacity of the Lungs (DLCO) >60% predicted (in children, O2 saturation
>92% on room air)
- Left ventricular ejection fraction >45% (in children, shortening fraction >26%)
7. Male and female subjects of child bearing potential must agree to use an effective
method of birth control to avoid pregnancy throughout the transplant procedure, while
on immunosuppression, and if the subject experiences any chronic GvHD.
Exclusion Criteria:
1. Prior bone marrow or peripheral blood HSCT within the last 6 (six) months
2. HLA-matched related or unrelated donor available
3. Any active, uncontrolled infection at the time of enrollment
4. Pregnant or lactating females
5. Any severe concurrent disease which, in the judgement of the investigator, would place
the patient at increased risk during participation in the study
6. Any subject with a history of significant renal, hepatic, pulmonary, or cardiac
dysfunction or on treatment to support cardiac dysfunction
7. HIV positive
8. Non-cooperative behavior or non-compliance of the patient and/or of his/her family
9. Received another investigational agent within 30 days of enrollment
10. Patients with Down's syndrome
Ages Eligible for Study
3 Years - 45 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
Gopin Saini, MBBS, CCRC
650-725-9032
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.