A Phase I/II Trial of HER-2/Neu Pulsed DC1 Vaccine Combined With Trastuzumab for Patients With DCIS



Status:Active, not recruiting
Conditions:Breast Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:1/5/2019
Start Date:June 2014
End Date:June 2020

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The purpose of the study is to treat patients with Ductal carcinoma in situ (DCIS) with a
combined treatment of DC1 vaccine with Trastuzumab. In this study the investigators will
assess the safety and immunogenicity of the combination therapy. The target population is
women over 18 years of age and have a diagnosis of DCIS that express HER-2 3 positive.
Participants will receive 6 vaccines along with 2 doses of trastuzumab.

This study began at the Abramson Cancer Center of the University of Pennsylvania and will
continue at H. Lee Moffitt Cancer Center and Research Institute.


Inclusion Criteria:

- Women >= 18 years.

- Ductal carcinoma in situ (DCIS) that express HER-2 3+ on 10% of the DCIS that have not
had definitive surgery are diagnosed by core biopsy or NL surgical biopsy with
positive margins.

- Patients that are ER+ will take anti-estrogen therapy for treatment of their DCIS
during vaccinations.

- Women of childbearing age with a negative pregnancy test documented prior to
enrollment.

- Eastern Cooperative Oncology Group (ECOG) Performance Status Score of 0 or 1.

- Women of childbearing potential must agree to use a medically acceptable form of birth
control during their participation in the study.

- Have voluntarily signed a written Informed Consent in accordance with institutional
policies after its contents have been fully explained to them.

Exclusion Criteria

- Pregnant or lactating.

- Positive for HIV or hepatitis C at baseline by self-report.

- Potential participants with coagulopathies, including thrombocytopenia with platelet
count <75,000, INR> 1.5 and partial thromboplastin time > 50 sec

- Major cardiac illness MUGA or ECHO <50% EF.

- Pre-existing medical illnesses or medications which might interfere with the study as
determined by Principal Investigator (PI).
We found this trial at
3
sites
3400 Civic Center Blvd
Philadelphia, Pennsylvania 19104
(215) 662-6065
Abramson Cancer Center of the University of Pennsylvania The Abramson Cancer Center of the University...
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Philadelphia, PA
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12902 USF Magnolia Dr
Tampa, Florida 33612
(888) 663-3488
H. Lee Moffitt Cancer Center & Research Institute Moffitt Cancer Center in Tampa, Florida, has...
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Tampa, FL
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3400 Civic Center Blvd
Philadelphia, Pennsylvania 19104
(215) 662-6065
Abramson Cancer Center of the University of Pennsylvania The Abramson Cancer Center of the University...
?
mi
from
Philadelphia, PA
Click here to add this to my saved trials