A Phase 2 interventional study of DC vaccine and aromatase inhibitor in Breast Cancer, sponsored by Inge Marie Svane. Withdrawn at 1 site in Denmark. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-05-31.
Sponsored by Inge Marie Svane · Phase 2, Interventional, and Treatment
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).
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Exclusion Criteria:
the HLA-A2 positive patients will be treated with AI, DC vaccines, Zadaxin and IL-2
Biological: DC vaccine
the HLA-A2 negative patients will receive AI only
Biological: DC vaccine · Drug: aromatase inhibitor
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
Also known as: 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
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
Also known as: Aromasin®, exemestane, Pfizer, Femar®, letrozol, Novartis Healthcare, Arimidex, anastrozol, AstraZeneca
To determine time to progression
Time frame: after 8 and 16 weeks
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
This study is withdrawn, as verified in May 2012. You cannot join it, but the record below documents what was studied.
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Inge Marie Svane