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

NCT00622401 | Terminated Phase 1 Results DMC

• 4 other identifiers: 03-221NCI 6040U01CA062490P30CA006516
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

stage IV breast cancer; dendritic cell vaccine; tumor fusion vaccine; IL-12

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Adverse Events Associated With Vaccination of Breast Cancer Patients With Dendritic Cell (DC)/Tumor Fusion Vaccine

  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 Outcomes (1)

• To Determine if Cellular and Humoral Immunity is Induced by Serial Vaccination With DC/Tumor Fusion Cells and rhIL-12.

  3 years

Study Arms (3)

Group 1

EXPERIMENTAL

Dendritic Cell/Tumor Fusion Vaccine Only

Biological: Dendritic Cell/Tumor Fusion Vaccine

Group 2

EXPERIMENTAL

Dendritic Cell/tumor fusion vaccine and low dose IL-12

Biological: Dendritic Cell/Tumor Fusion Vaccine; Drug: Interleukin-12

Group 3

EXPERIMENTAL

Dendritic Cell/tumor fusion vaccine and higher dose IL-12

Biological: Dendritic Cell/Tumor Fusion Vaccine; Drug: Interleukin-12

Interventions

Dendritic Cell/Tumor Fusion Vaccine BIOLOGICAL

Vaccine is derived from the participants dendritic cells and tumor cells

Also known as: DC/tumor cell fusion vaccine

Group 1; Group 2; Group 3

Interleukin-12 DRUG

Given subcutaneously at dose of 30ng/kg

Also known as: IL-12, rhIL-12

Group 2

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Beth Israel Deaconess Medical Center: lead
• Dana-Farber Cancer Institute: collaborator
• Brigham and Women's Hospital: collaborator
• Harvard Medical School (HMS and HSDM): collaborator
• United States Department of Defense: collaborator
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Interleukin-12

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Interleukins; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Limitations and Caveats

In the conduct of the study, it became apparent that the setting of advanced breast cancer with malignant effusions/ascites for vaccine generation was a difficult setting for evaluation of an immune based therapy.

Results Point of Contact

• Title: David Avigan, MD
• Organization: Beth Israel Deaconess Medical Center

davigan@bidmc.harvard.edu

617-667-9920

Study Officials

• David Avigan, MD

  Beth Israel Deaconess Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 14, 2008
• First Posted: February 25, 2008
• Study Start: December 1, 2009
• Primary Completion: October 1, 2014
• Study Completion: October 1, 2014
• Last Updated: November 14, 2017
• Results First Posted: March 16, 2016

Record last verified: 2017-10

Locations

US (1)