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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00622401
Recruitment Status : Terminated
First Posted : February 25, 2008
Results First Posted : March 16, 2016
Last Update Posted : November 14, 2017
Sponsor:
Collaborators:
Dana-Farber Cancer Institute
Brigham and Women's Hospital
Harvard Medical School (HMS and HSDM)
United States Department of Defense
National Cancer Institute (NCI)
Information provided by (Responsible Party):
David Avigan, MD, Dana-Farber Cancer Institute

Study Description
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Brief 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.


Condition or disease Intervention/treatment Phase
Breast Cancer Biological: Dendritic Cell/Tumor Fusion Vaccine Drug: Interleukin-12 Phase 1 Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Vaccination of Patients With Breast Cancer With Dendritic Cell/Tumor Fusions and IL-12
Study Start Date : December 2009
Actual Primary Completion Date : October 2014
Actual Study Completion Date : October 2014

Resource links provided by the National Library of Medicine


Arms and Interventions
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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 Name: 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 Name: DC/tumor cell fusion vaccine

Drug: Interleukin-12
Given subcutaneously at dose of 30ng/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 Name: DC/tumor cell fusion vaccine

Drug: Interleukin-12
Given subcutaneously at dose of 100ng/kg
Other Names:
  • IL-12
  • rhIL-12


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00622401


Locations
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United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Beth Israel Deaconess Medical Center
Dana-Farber Cancer Institute
Brigham and Women's Hospital
Harvard Medical School (HMS and HSDM)
United States Department of Defense
National Cancer Institute (NCI)
Investigators
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Principal Investigator: David Avigan, MD Beth Israel Deaconess Medical Center
More Information
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Responsible Party: David Avigan, MD, Principal Investigator, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT00622401    
Obsolete Identifiers: NCT00731406
Other Study ID Numbers: 03-221
NCI 6040
U01CA062490 ( U.S. NIH Grant/Contract )
P30CA006516 ( U.S. NIH Grant/Contract )
First Posted: February 25, 2008    Key Record Dates
Results First Posted: March 16, 2016
Last Update Posted: November 14, 2017
Last Verified: October 2017
Keywords provided by David Avigan, MD, Dana-Farber Cancer Institute:
stage IV breast cancer
dendritic cell vaccine
tumor fusion vaccine
IL-12
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Interleukin-12
Vaccines
Immunologic Factors
 Physiological Effects of Drugs
Adjuvants, Immunologic
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents