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Dendritic Cell Based Therapy of Metastatic Breast Cancer

Primary Purpose

Metastatic Breast Cancer

Status
Terminated
Phase
Phase 1
Locations
Denmark
Study Type
Interventional
Intervention
Onco-peptide loaded autologous dendritic cells
Sponsored by
Herlev Hospital
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metastatic Breast Cancer focused on measuring breast cancer, dendritic cells, vaccine

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Histologically proven progressive metastatic or locally advanced breast cancer No standard treatment indicated Age: > 18 WHO-Performance Status 0-1 At least tone measurable tumor lesions according to the RECIST criteria. Expression of the HLA-A2 tissue type Life expectancy more than 3 months Acceptable CBC and blood chemistry results Written informed consent Exclusion Criteria: Patients with a history of any other neoplastic disease less than 5 years ago (excepting treated carcinomas in situ of the cervix and basal/squamous cell carcinomas of the skin). Patients with metastatic disease in the central nervous system (CNS). Patients with other significant illness including severe allergy, asthma, angina pectoris or congestive heart failure. Patients with acute or chronic infection including HIV, hepatitis and tuberculosis. Patients who are pregnant. Patients who have received antineoplastic therapy including chemotherapy or immunotherapy less than 4 weeks before beginning the trial. Patients who receive corticosteroids or other immunosuppressive agents. Patients with active autoimmune diseases such as lupus erythematosus, rheumatoid arthritis or thyroiditis.

Sites / Locations

  • Department of Oncology

Outcomes

Primary Outcome Measures

Primary aim of the study is to evaluate tolerability and safety of the treatment.

Secondary Outcome Measures

Secondary aims: evaluation of treatment induced immune response and clinical response.

Full Information

First Posted
September 12, 2005
Last Updated
January 2, 2008
Sponsor
Herlev Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00197925
Brief Title
Dendritic Cell Based Therapy of Metastatic Breast Cancer
Official Title
Vaccination With Autologous Dendritic Cells Pulsed With Onco-Peptides for Treatment of Patients With Metastatic Breast Cancer.A Phase I/II Study
Study Type
Interventional

2. Study Status

Record Verification Date
January 2008
Overall Recruitment Status
Terminated
Why Stopped
all patients recruited
Study Start Date
September 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Herlev Hospital

4. Oversight

5. Study Description

Brief Summary
The study aim to show if vaccination with autologous dendritic cells pulsed with onco-peptides in combination with adjuvant cytokine can induce a measurable immune response in patients with metastatic breast cancer, and to evaluate the clinical effect (objective response rate) of the vaccination regime.
Detailed Description
HLA A2 positive patients are treated with PADRE and oncopeptide pulsed DC; p53, survivin and telomerase peptides. Each patient is given 6 immunizations with at least 5x106 peptide/lysate pulsed autologous DC. Vaccination 1-4 is given weekly and 4-6 at 2-week intervals. Those patients who exhibit stable disease, partial response or complete response after 6 injections will be given 4 more vaccinations at 2-week interval. The vaccine is applied by either intranodal or intradermal injection near the inguinal region. For adjuvant used IL-2 2 MIU sc. day 2-6. Scans and re-staging tests are performed at scheduled intervals throughout the study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Breast Cancer
Keywords
breast cancer, dendritic cells, vaccine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
Onco-peptide loaded autologous dendritic cells
Primary Outcome Measure Information:
Title
Primary aim of the study is to evaluate tolerability and safety of the treatment.
Secondary Outcome Measure Information:
Title
Secondary aims: evaluation of treatment induced immune response and clinical response.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Histologically proven progressive metastatic or locally advanced breast cancer No standard treatment indicated Age: > 18 WHO-Performance Status 0-1 At least tone measurable tumor lesions according to the RECIST criteria. Expression of the HLA-A2 tissue type Life expectancy more than 3 months Acceptable CBC and blood chemistry results Written informed consent Exclusion Criteria: Patients with a history of any other neoplastic disease less than 5 years ago (excepting treated carcinomas in situ of the cervix and basal/squamous cell carcinomas of the skin). Patients with metastatic disease in the central nervous system (CNS). Patients with other significant illness including severe allergy, asthma, angina pectoris or congestive heart failure. Patients with acute or chronic infection including HIV, hepatitis and tuberculosis. Patients who are pregnant. Patients who have received antineoplastic therapy including chemotherapy or immunotherapy less than 4 weeks before beginning the trial. Patients who receive corticosteroids or other immunosuppressive agents. Patients with active autoimmune diseases such as lupus erythematosus, rheumatoid arthritis or thyroiditis.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Inge Marie Svane, MD, PHD
Organizational Affiliation
Department of Oncology, Copenhagen University Hospital, Herlev, Herlev Ringvej 75, DK-2730 Herlev, Denmark
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Oncology
City
Herlev
ZIP/Postal Code
2970
Country
Denmark

12. IPD Sharing Statement

Citations:
PubMed Identifier
14985857
Citation
Svane IM, Pedersen AE, Johnsen HE, Nielsen D, Kamby C, Gaarsdal E, Nikolajsen K, Buus S, Claesson MH. Vaccination with p53-peptide-pulsed dendritic cells, of patients with advanced breast cancer: report from a phase I study. Cancer Immunol Immunother. 2004 Jul;53(7):633-41. doi: 10.1007/s00262-003-0493-5. Epub 2004 Feb 25.
Results Reference
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Dendritic Cell Based Therapy of Metastatic Breast Cancer

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