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

October 12, 2017 updated by: David Avigan, MD, Beth Israel Deaconess Medical Center

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

TUMOR COLLECTION: Tumor cells will be collected from the participant to make the study vaccine. Based on the location of the tumor, a decision will be made as to the best approach to obtain these cells.

DENDRITIC CELL COLLECTION: Participants will undergo a procedure known as leukapheresis to obtain their dendritic cells (this procedure may be done before or after the tumor cells have been obtained). This procedure takes about 2-4 hours. If not enough cells are collected, the participant may be asked to return for an additional leukapheresis procedure. If sufficient number of cells are obtained, tumor cells and dendritic cells will then be fused (combined together to make one larger cell) together in the laboratory and divided into the appropriate dose for administration.

TREATMENT: Treatment will consist of an injection of tumor cells fused with dendritic cells under the skin every 3 weeks for a total of 9 weeks. The dose that the participant receives will depend on the total number of fusion cells that are made.

STUDY COHORTS: The first group of three participants will receive the DC/Tumor Fusion study vaccine alone. The next group of 3 participants will receive the DC/Tumor Fusion study vaccine with a low dose of Il-12. If there are no significant side effects the following groups of subjects will be treated with the DC/Tumor Fusion study vaccine and a higher dose of Il-12.

PATIENT MONITORING: Participants will be carefully monitored during the study period and the following tests and procedures will be performed: physical exams (weekly); blood collections (weekly); DC/Tumor Fusion study vaccine Journal (for the participant to record any side effects or other medications they may be taking); tumor cells skin test (before the first vaccine and one month following the last vaccine); skin biopsy at the site of the vaccination administration, accessible tumor site, or if there is a local reaction site.

Study Type

Interventional

Enrollment (Actual)

8

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Beth Israel Deaconess Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Stage IV breast cancer with measurable disease and accessible tumor
  • ECOG Performance Status 0-2 with greater than six week life expectancy
  • 18 years of age or older
  • Laboratory values as outlined in the protocol

Exclusion Criteria:

  • Patients must not have received other immunotherapy treatment in the three months prior to the initial vaccination
  • Patients may not be on herceptin therapy during this protocol and may not have received it for four weeks prior to initial vaccination
  • Patients must not have received weekly chemotherapy or hormonal treatment for two weeks prior to the initial vaccination and must not have received monthly chemotherapy for four weeks prior to the initial vaccination
  • Clinical evidence of CNS disease
  • Clinically significant autoimmune disease
  • Patients who are HIV+
  • Serious intercurrent illness such as infection requiring IV antibiotics, or significant cardiac disease characterized by significant arrhythmia, ischemic coronary disease or congestive heart failure
  • Pregnant of lactating women will be excluded, all premenopausal women must undergo pregnancy testing

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group 1
Dendritic Cell/Tumor Fusion Vaccine Only
Biological: Dendritic Cell/Tumor Fusion Vaccine
Vaccine is derived from the participants dendritic cells and tumor cells
Other Names:
  • DC/tumor cell fusion vaccine
Experimental: Group 2
Dendritic Cell/tumor fusion vaccine and low dose IL-12
Biological: Dendritic Cell/Tumor Fusion Vaccine
Vaccine is derived from the participants dendritic cells and tumor cells
Other Names:
  • DC/tumor cell fusion vaccine
Drug: Interleukin-12
Given subcutaneously at dose of 30ng/kg
Other Names:
  • IL-12
  • rhIL-12
Drug: Interleukin-12
Given subcutaneously at dose of 100ng/kg
Other Names:
  • IL-12
  • rhIL-12
Experimental: Group 3
Dendritic Cell/tumor fusion vaccine and higher dose IL-12
Biological: Dendritic Cell/Tumor Fusion Vaccine
Vaccine is derived from the participants dendritic cells and tumor cells
Other Names:
  • DC/tumor cell fusion vaccine
Drug: Interleukin-12
Given subcutaneously at dose of 30ng/kg
Other Names:
  • IL-12
  • rhIL-12
Drug: Interleukin-12
Given subcutaneously at dose of 100ng/kg
Other Names:
  • IL-12
  • rhIL-12

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Adverse Events Associated With Vaccination of Breast Cancer Patients With Dendritic Cell (DC)/Tumor Fusion Vaccine
Time Frame: 3 years
Using CTCAE version 3, adverse events associated with the intervention were captured throughout the treatment portion of the study. All adverse events were then compiled and the number of patients who experienced these adverse events was recorded.
3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To Determine if Cellular and Humoral Immunity is Induced by Serial Vaccination With DC/Tumor Fusion Cells and rhIL-12.
Time Frame: 3 years
This outcome was not measured because no patients were treated with rhIL-12.
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beth Israel Deaconess Medical Center

Collaborators

Harvard Medical School (HMS and HSDM)
National Cancer Institute (NCI)
Dana-Farber Cancer Institute
United States Department of Defense
Brigham and Women's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2009

Primary Completion (Actual)

October 1, 2014

Study Completion (Actual)

October 1, 2014

Study Registration Dates

First Submitted

February 14, 2008

First Submitted That Met QC Criteria

February 14, 2008

First Posted (Estimate)

February 25, 2008

Study Record Updates

Last Update Posted (Actual)

November 14, 2017

Last Update Submitted That Met QC Criteria

October 12, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 03-221
  • U01CA062490 (U.S. NIH Grant/Contract)
  • P30CA006516 (U.S. NIH Grant/Contract)
  • NCI 6040

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Breast Cancer

Clinical Trials on Dendritic Cell/Tumor Fusion Vaccine

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Gabon

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe