Dendritic Cell Based Therapy of Metastatic Breast Cancer

NCT ID: NCT00197925

Last Updated: 2008-01-03

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-09-30

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.

Conditions

Metastatic Breast Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Onco-peptide loaded autologous dendritic cells

Intervention Type: BIOLOGICAL

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Herlev Hospital

OTHER

Sponsor Role: lead

Principal Investigators

Inge Marie Svane, MD, PHD

Role: PRINCIPAL_INVESTIGATOR

Department of Oncology, Copenhagen University Hospital, Herlev, Herlev Ringvej 75, DK-2730 Herlev, Denmark

Locations

Department of Oncology

Herlev, , Denmark

Countries

Denmark

References

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.

Reference Type: BACKGROUND

PMID: 14985857 (View on PubMed)

Other Identifiers

MA0415

Identifier Type: -

Identifier Source: org_study_id