Vaccination of Patients With Breast Cancer With Dendritic Cell/Tumor Fusions and IL-12

NCT00622401 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2017-11-14

Study results available
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Summary

The purpose of this study is to test the safety of an investigational Dendritic Cell/Tumor Fusion vaccine given with IL-12 for patients with breast cancer.

RATIONALE: Vaccines made from a person's tumor cells and white blood cells may help the body build an effective immune response to kill tumor cells. Interleukin-12 may stimulate the white blood cells to kill tumor cells. Giving vaccine therapy together with interleukin-12 may kill more tumor cells.

PURPOSE: This phase I/II trial is studying the side effects and best dose of interleukin-12 when given together with vaccine therapy and to see how well they work in treating women with stage IV breast cancer.

Conditions

Interventions

BIOLOGICAL

Dendritic Cell/Tumor Fusion Vaccine

Vaccine is derived from the participants dendritic cells and tumor cells

DRUG

Interleukin-12

Given subcutaneously at dose of 30ng/kg

DRUG

Interleukin-12

Given subcutaneously at dose of 100ng/kg

Sponsors & Collaborators

Principal Investigators

  • David Avigan, MD · Beth Israel Deaconess Medical Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-12-31
Primary Completion
2014-10-31
Completion
2014-10-31

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 NCT00622401 on ClinicalTrials.gov