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Evaluation of p53peptide-pulsed Dendritic Cells in Combination With an Aromatase Inhibitor as a Treatment for Patients With Breast Cancer With Disease Recurrence After Adjuvant or First Line Endocrine Therapy.


Phase 2
18 Years
N/A
Not Enrolling
Female
Breast Cancer

Thank you

Trial Information

Evaluation of p53peptide-pulsed Dendritic Cells in Combination With an Aromatase Inhibitor as a Treatment for Patients With Breast Cancer With Disease Recurrence After Adjuvant or First Line Endocrine Therapy.


Only patients who have tumors > 5 % positive for p53 by IHC can be referred to this
treatment. All patients will receive standard dosage of AI +/- p53-DC vaccination. Patients
who express HLA-A2 will also receive DC vaccination. Patients that do not express HLA-A2
will receive only AI and be regarded as controls.

The vaccination regime consists of primary 10 intradermal injections of 1-2 weeks interval
(q1w x 4 → q2w x 6) with p53 peptide-pulsed dendritic cells, followed by monthly injections
until progression; proleukin and Zadaxin are used as vaccine adjuvants.

Defined procedures are employed for generation of autologous dendritic cells for clinical
application in a classified laboratory. Unmobilized leukapheresis will be used for isolation
of large-scale mononuclear cells, and dendritic cells will be generated from monocytes by
cytokine stimulation and loaded with p53 peptides. Frozen preparations of dendritic cells
will be prepared using automated cryopreservation.Each patient will receive a minimum of
5x10^6 dendritic cells per treatment supplemented with interleukin-2 6 MIU/m² sc per vaccine
and 1.6 mg Thymosin 1 alpha sc x 2/week.

Toxicity including autoimmunity will be evaluated using the common Toxicity Criteria (CTC).


Inclusion Criteria:



- Patients with histological proven metastatic or locally advanced ER+/PGR+ breast
cancer in progression after receiving 1. line endocrine therapy.

- Further inclusion criteria: p53+ tumour, PS≤1, postmenopausal. Age >18, PS ≤ 1 and
acceptable CBC and blood chemistry results

Exclusion Criteria:

- Patients with a history of any other neoplastic disease less than 5 years ago
(excepting treated carcinoma in situ of the cervix and basal/squamous carcinoma of
the skin)

- Patients with metastatic disease in the central nervous system

- Patients with other significant illness including severe allergy, asthma, DM, angina
pectoris or congestive heart failure

- Patients with acute or chronic infection including HIV, hepatitis og TB

- Patients who received antineoplastic therapy including chemotherapy, radiation,
immunotherapy or other agents, less than 4 weeks before the beginning of the trial

- Patients who received corticosteroids or other immunosuppressive agents

- Patients with active autoimmune diseases such as lupus erythematosus, rheumatoid
arthritis or thyroiditis

- Severe hypercalcemia

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

To determine time to progression

Outcome Time Frame:

after 8 and 16 weeks

Safety Issue:

No

Principal Investigator

Inge Marie Svane, prof MD

Investigator Role:

Study Director

Investigator Affiliation:

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

Authority:

Denmark: Danish Medicines Agency

Study ID:

MA 0822

NCT ID:

NCT00935558

Start Date:

July 2009

Completion Date:

Related Keywords:

  • Breast Cancer
  • dendritic cell
  • cancer vaccine
  • breast cancer
  • aromatase inhibitor
  • Zadaxin
  • Breast Neoplasms

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