Dendritic Cell Based Therapy for Breast Cancer Patients

This study has been withdrawn prior to enrollment.
(no patients enrolled)
Sponsor:
Information provided by (Responsible Party):
Inge Marie Svane, Herlev Hospital
ClinicalTrials.gov Identifier:
NCT00935558
First received: July 8, 2009
Last updated: May 30, 2012
Last verified: May 2012

July 8, 2009
May 30, 2012
July 2009
May 2012   (final data collection date for primary outcome measure)
To determine time to progression [ Time Frame: after 8 and 16 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00935558 on ClinicalTrials.gov Archive Site
To evaluate safety of DC vaccination in combination with AI, to evaluate clinical tumor response, to evaluate treatment induced immune response to p53 end to evaluate duration of tumor and immune responses [ Time Frame: Weekly the first 4 weeks, thereafter biweekly for five months, thereafter monthly ] [ Designated as safety issue: Yes ]
To evaluate safety of DC vaccination in combination with Exemestane, to evaluate clinical tumor response, to evaluate treatment induced immune response to p53 end to evaluate duration of tumor and immune responses [ Time Frame: Weekly the first 4 weeks, thereafter biweekly for five months, thereafter monthly ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Dendritic Cell Based Therapy for Breast Cancer Patients
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.

The primary aim of this study is to investigate time to progression in breast cancer patients vaccinated with autologous dendritic cells pulsed with peptides in combination with adjuvant aromatase inhibitor (AI), Thymosin 1 alpha and interleukin-2. The secondary aim is to investigate whether a measurable immune response can be induced, and to evaluate the clinical effect (objective response rate) of the vaccination regime.

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).

Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Breast Cancer
  • Biological: DC vaccine
    DC vaccination regime consist of primary 10 intradermal injections of 1-2 weeks interval. At the time of each vaccine 6 MIU/m² IL-2 will be administered sc. Zadaxin 1.6 mg is injected sc twice a week. and tablet Aromatase inhibitor is administered ; Exemestane 25 mg (tablet) is administered PO daily or Femar 2,5 mg (tablet) is administered PO daily or Arimidex 1 mg (tablet) is administered PO daily
    Other Names:
    • dendritic cell vaccine
    • Thymosin 1 alpha, Zadaxin®, Sigma-Tau
    • Interleukin-2, Proleukin®, Chiron B.V.
    • Aromatase inhibitor:Exemestane, (Aromasin®), Pfizer
    • or Femar®,letrozol, Novartis Healthcare
    • or Arimidex®, anastrozol, AstraZeneca
  • Drug: aromatase inhibitor
    Exemestane 25 mg (tablet) is administered PO daily or Femar 2,5 mg (tablet) is administered PO daily or Arimidex 1 mg (tablet) is administered PO daily
    Other Names:
    • Aromasin®, exemestane, Pfizer
    • Femar®, letrozol, Novartis Healthcare
    • Arimidex, anastrozol, AstraZeneca
  • Experimental: Aromatase inhibitor and DC vaccination
    the HLA-A2 positive patients will be treated with AI, DC vaccines, Zadaxin and IL-2
    Intervention: Biological: DC vaccine
  • Active Comparator: Aromatase inhibitor
    the HLA-A2 negative patients will receive AI only
    Interventions:
    • Biological: DC vaccine
    • Drug: aromatase inhibitor

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
Not Provided
May 2012   (final data collection date for primary outcome measure)

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
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT00935558
MA 0822
Yes
Inge Marie Svane, Herlev Hospital
Inge Marie Svane
Not Provided
Study Director: Inge Marie Svane, prof MD Department of Oncology, Copenhagen University Hospital, Herlev, Herlev Ringvej 75, DK-2730 Herlev; Denmark
Herlev Hospital
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP