Transfected Dendritic Cell Based Therapy for Patients With Breast Cancer or Malignant Melanoma

This study has been completed.
Information provided by (Responsible Party):
Inge Marie Svane, Herlev Hospital Identifier:
First received: September 16, 2009
Last updated: August 18, 2015
Last verified: August 2015

The primary aim of this study is to evaluate the toxicity of the vaccine and the combination of the vaccine and Cyclophosphamide, and to evaluate the immune response induced by the vaccine. The secondary aim is to investigate the clinical tumour response and duration of tumour and immune response.

Condition Intervention Phase
Breast Cancer
Malignant Melanoma
Biological: DC vaccine
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Evaluation of Dendritic Cells Transfected With Survivin, hTERT and p53 mRNA as a Treatment for Patients With Metastatic Breast Cancer or Malignant Melanoma

Resource links provided by NLM:

Further study details as provided by Herlev Hospital:

Primary Outcome Measures:
  • to evaluate the toxicity of the vaccine in combination with Cyclophosphamide [ Time Frame: biweekly ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • to investigate the clinical tumor response and the duration [ Time Frame: after 12 weeks ] [ Designated as safety issue: No ]
  • to evaluate the duration of tumor and immunoresponse [ Time Frame: 3, 6, 9 months ] [ Designated as safety issue: No ]
  • to evaluate immune response [ Time Frame: at 8 and 12 weeks ] [ Designated as safety issue: No ]

Enrollment: 31
Study Start Date: September 2009
Study Completion Date: May 2014
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: DC vaccination and Cyclophosphamide Biological: DC vaccine
DC vaccination, one vaccine biweekly
Other Names:
  • dendritic cell vaccine
  • Cyclophosphamide, Sendoxan®, Baxter

Detailed Description:

Phase I trial. Single center study; patients will be referred to the study center from other institutions in Denmark. 14 patients will be included in this phase I trial DC vaccination regime consists of primary 6 biweekly intradermal injections with transfected dendritic cells, followed by monthly injections until progression; Cyclophosphamide is used as vaccine adjuvant.

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 transfected with mRNA encoding for hTERT, survivin and p53 if the tumour express p53. Frozen preparations of dendritic cells will be prepared using automated cryopreservation. Each patient will receive a minimum of 1x106 dendritic cells per treatment supplemented with Cyclophosphamide 50 mg twice a day every second week. Toxicity including autoimmunity will be evaluated using the Common Toxicity Criteria (CTC).


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Histological verified metastatic breast cancer or malignant melanoma, in progression
  2. ≥ 18 years
  3. the patient must be habil
  4. Performance status ≤ 1 on Zubrod-ECOG-WHO-scale
  5. Leukocytes and platelets must be ≥normal. Hg ≥ 6.0
  6. creatinin must be normal
  7. Liverparametre <2.5 x normal. Bilirubin <30
  8. Expected survival > 3 months
  9. Informed consent

11. At least one measurable lesion according to RECIST criteria.

Exclusion Criteria:

  1. Indication for chemotherapy
  2. Other malignancies
  3. Brain metastases
  4. severe medical condition
  5. Acute/chronic infection with ex. HIV, hepatitis, tuberculose
  6. Severe allergy
  7. Autoimmune disease
  8. Other treatment with immune suppressing agents, other anticancer agents or experimental drugs
  9. Uncontrolled hypercalcemia.
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Please refer to this study by its identifier: NCT00978913

Department of Oncology, Herlev University Hospital
Herlev, Denmark, Dk 2730
Sponsors and Collaborators
Inge Marie Svane
Study Director: Inge Marie Svane, prof.MD Department of Oncology, Herlev University Hospital, Herlev Ringvej 75,2730 Herlev
  More Information

No publications provided

Responsible Party: Inge Marie Svane, Professor, MD, Herlev Hospital Identifier: NCT00978913     History of Changes
Other Study ID Numbers: AA 0914
Study First Received: September 16, 2009
Last Updated: August 18, 2015
Health Authority: Denmark: Danish Medicines Agency

Keywords provided by Herlev Hospital:
dendritic cell
breast cancer
malignant melanoma

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Neuroectodermal Tumors
Neuroendocrine Tumors
Nevi and Melanomas
Skin Diseases
Alkylating Agents
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Antirheumatic Agents
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Myeloablative Agonists
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses processed this record on October 13, 2015