Dendritic Cell Based Therapy for Breast Cancer Patients

NCT00935558 | Withdrawn Phase 2 DMC

• 1 other identifier: MA 0822
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

dendritic cell; cancer vaccine; breast cancer; aromatase inhibitor; Zadaxin

Outcome Measures

Primary Outcomes (1)

• To determine time to progression

  after 8 and 16 weeks

Secondary Outcomes (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

  Weekly the first 4 weeks, thereafter biweekly for five months, thereafter monthly

Study Arms (2)

Aromatase inhibitor and DC vaccination

EXPERIMENTAL

the HLA-A2 positive patients will be treated with AI, DC vaccines, Zadaxin and IL-2

Biological: DC vaccine

Aromatase inhibitor

ACTIVE COMPARATOR

the HLA-A2 negative patients will receive AI only

Biological: DC vaccine; Drug: aromatase inhibitor

Interventions

DC vaccine BIOLOGICAL

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

Aromatase inhibitor; Aromatase inhibitor and DC vaccination

aromatase inhibitor DRUG

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

Aromatase inhibitor

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Inge Marie Svane: lead

Study Sites (1)

Department of Oncology, Copenhagen University Hospital, Herlev

Herlev, 2730, Denmark

Location

Related Publications (2)

• Svane IM, Pedersen AE, Johansen JS, Johnsen HE, Nielsen D, Kamby C, Ottesen S, Balslev E, Gaarsdal E, Nikolajsen K, Claesson MH. Vaccination with p53 peptide-pulsed dendritic cells is associated with disease stabilization in patients with p53 expressing advanced breast cancer; monitoring of serum YKL-40 and IL-6 as response biomarkers. Cancer Immunol Immunother. 2007 Sep;56(9):1485-99. doi: 10.1007/s00262-007-0293-4. Epub 2007 Feb 7.

  PMID: 17285289 BACKGROUND

• 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. doi: 10.1007/s00262-003-0493-5. Epub 2004 Feb 25.

  PMID: 14985857 BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms

Interventions

lentiviral minigene vaccine of COVID-19 coronavirus; Thymalfasin; Interleukin-2; aldesleukin; exemestane; Anastrozole; Aromatase Inhibitors; Letrozole

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Thymosin; Thymus Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptide Hormones; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Interleukins; Cytokines; Intercellular Signaling Peptides and Proteins; Lymphokines; Biological Factors; Nitriles; Organic Chemicals; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Steroid Synthesis Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Estrogen Antagonists; Hormone Antagonists; Physiological Effects of Drugs

Study Officials

• Inge Marie Svane, prof MD

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

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof, MD, PhD

Study Record Dates

• First Submitted: July 8, 2009
• First Posted: July 9, 2009
• Study Start: July 1, 2009
• Primary Completion: May 1, 2012
• Last Updated: May 31, 2012

Record last verified: 2012-05

Locations

DK (1)