Dendritic Cell Based Therapy of Metastatic Breast Cancer

Metastatic Breast Cancer Clinical Trial

Official title:

Vaccination With Autologous Dendritic Cells Pulsed With Onco-Peptides for Treatment of Patients With Metastatic Breast Cancer.A Phase I/II Study

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00197925
• Other study ID #: MA0415
• Status: Terminated
• Phase: Phase 1/Phase 2
• First received: September 12, 2005
• Last updated: January 2, 2008
• Start date: September 2004

Study information

• Verified date: January 2008
• Source: Herlev Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Medicines Agency
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 40
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Neoplasms
• Metastatic Breast Cancer

Intervention

Biological:
• Onco-peptide loaded autologous dendritic cells

Locations

Country	Name	City	State
Denmark	Department of Oncology	Herlev

Sponsors (1)

Lead Sponsor	Collaborator
Herlev Hospital

Country where clinical trial is conducted

Denmark, 

References & Publications (1)

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. Epub 2004 Feb 25. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary aim of the study is to evaluate tolerability and safety of the treatment.
Secondary	Secondary aims: evaluation of treatment induced immune response and clinical response.