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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00197925
Other study ID # MA0415
Secondary ID
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
Est. completion date
Est. primary completion date
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


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.
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