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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02336984
• Other study ID #: UPCC 03114
• Status: Withdrawn
• Phase: Phase 1/Phase 2
• Start date: June 2014
• Est. completion date: April 4, 2016

Study information

• Verified date: January 2021
• Source: H. Lee Moffitt Cancer Center and Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: April 4, 2016
• Est. primary completion date: April 4, 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Breast Cancer

Intervention

Biological:
• HER-2 pulsed DC1
Vaccine administered weekly, with no more than 4 weeks delay over the course of 6 vaccines.

Drug:
• 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.
• pertuzumab
Pertuzumab 420 mg IV will be given at the same time as trastuzumab.

Locations

Country	Name	City	State
United States	Abramson Cancer Center of the University of Pennsylvania	Philadelphia	Pennsylvania
United States	H. Lee Moffitt Cancer Center and Research Institute	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
H. Lee Moffitt Cancer Center and Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occurrence of Related Adverse Events (AEs)	Occurrence of AEs related to study treatment. Adverse Events will be graded according to NCI Common Toxicity Criteria for Adverse Events (CTCAE) V 4.02.	5 years