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Dendritic Cell Based Therapy for Breast Cancer Patients

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ClinicalTrials.gov Identifier: NCT00935558
Recruitment Status : Withdrawn (no patients enrolled)
First Posted : July 9, 2009
Last Update Posted : May 31, 2012
Sponsor:
Information provided by (Responsible Party):
Inge Marie Svane, Herlev Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Breast Cancer Biological: DC vaccine Drug: aromatase inhibitor Phase 2

Detailed Description:

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).


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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.
Study Start Date : July 2009
Actual Primary Completion Date : May 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Aromatase inhibitor and DC vaccination
the HLA-A2 positive patients will be treated with AI, DC vaccines, Zadaxin and IL-2
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
Active Comparator: Aromatase inhibitor
the HLA-A2 negative patients will receive AI only
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



Primary Outcome Measures :
  1. To determine time to progression [ Time Frame: after 8 and 16 weeks ]

Secondary Outcome Measures :
  1. 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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00935558


Locations
Denmark
Department of Oncology, Copenhagen University Hospital, Herlev
Herlev, Denmark, 2730
Sponsors and Collaborators
Inge Marie Svane
Investigators
Study Director: Inge Marie Svane, prof MD Department of Oncology, Copenhagen University Hospital, Herlev, Herlev Ringvej 75, DK-2730 Herlev; Denmark

Publications:
Responsible Party: Inge Marie Svane, Prof, MD, PhD, Herlev Hospital
ClinicalTrials.gov Identifier: NCT00935558     History of Changes
Other Study ID Numbers: MA 0822
First Posted: July 9, 2009    Key Record Dates
Last Update Posted: May 31, 2012
Last Verified: May 2012

Keywords provided by Inge Marie Svane, Herlev Hospital:
dendritic cell
cancer vaccine
breast cancer
aromatase inhibitor
Zadaxin

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Vaccines
Thymalfasin
Exemestane
Anastrozole
Letrozole
Interleukin-2
Aromatase Inhibitors
Lactitol
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Cathartics
Gastrointestinal Agents
Antineoplastic Agents, Hormonal
Adjuvants, Immunologic