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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE1/PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2014-06-30

Study Completion Date

2016-04-04

Brief Summary

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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.

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Detailed Description

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Conditions

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Breast Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Combination Therapy

Combination Therapy: HER-2 pulsed DC1 vaccine with trastuzumab and pertuzumab.

Group Type EXPERIMENTAL

HER-2 pulsed DC1

Intervention Type BIOLOGICAL

Vaccine administered weekly, with no more than 4 weeks delay over the course of 6 vaccines.

trastuzumab

Intervention Type DRUG

The loading dose of Trastuzumab will be 8 mg/kg and the maintenance dose given week 4 will be 6 mg/kg, both standard doses of trastuzumab.

pertuzumab

Intervention Type DRUG

Pertuzumab 420 mg IV will be given at the same time as trastuzumab.

Interventions

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HER-2 pulsed DC1

Vaccine administered weekly, with no more than 4 weeks delay over the course of 6 vaccines.

Intervention Type BIOLOGICAL

trastuzumab

The loading dose of Trastuzumab will be 8 mg/kg and the maintenance dose given week 4 will be 6 mg/kg, both standard doses of trastuzumab.

Intervention Type DRUG

pertuzumab

Pertuzumab 420 mg IV will be given at the same time as trastuzumab.

Intervention Type DRUG

Other Intervention Names

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vaccine Herceptin Perjeta

Eligibility Criteria

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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).

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No