DC Vaccine for Patients With Ductal Carcinoma In Situ

NCT02061332 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 58

Last updated 2020-04-10

No results posted yet for this study

Summary

Women who are diagnosed with Her-2/neu over-expressing DCIS will receive DC1 vaccines by intranodal, intralesional, or both routes of administration. The primary objective will be safety and administration with secondary objectives of immune activation and clinical response.

Conditions

Interventions

BIOLOGICAL

HER-2 Pulsed Dendritic cell Vaccine

6 weekly HER-2 pulsed dendritic cell vaccines will be administered to subjects in each of the 3 arms.

Sponsors & Collaborators

  • Abramson Cancer Center at Penn Medicine

    lead OTHER

Principal Investigators

  • Brian J Czerniecki, M.D., Ph.D. · University of Pennsylvania

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-07-31
Primary Completion
2014-08-08
Completion
2015-10-07

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02061332 on ClinicalTrials.gov