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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00978913
Recruitment Status : Completed
First Posted : September 17, 2009
Last Update Posted : August 19, 2015
Sponsor:
Information provided by (Responsible Party):
Inge Marie Svane, Herlev Hospital

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Breast Cancer Malignant Melanoma Biological: DC vaccine Phase 1

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).

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 31 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : September 2009
Actual Primary Completion Date : August 2013
Actual Study Completion Date : May 2014

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: DC vaccination and Cyclophosphamide Biological: DC vaccine
DC vaccination, one vaccine biweekly
Other Names:
  • dendritic cell vaccine
  • Cyclophosphamide, Sendoxan®, Baxter


Outcome Measures
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Primary Outcome Measures :
  1. to evaluate the toxicity of the vaccine in combination with Cyclophosphamide [ Time Frame: biweekly ]

Secondary Outcome Measures :
  1. to investigate the clinical tumor response and the duration [ Time Frame: after 12 weeks ]
  2. to evaluate the duration of tumor and immunoresponse [ Time Frame: 3, 6, 9 months ]
  3. to evaluate immune response [ Time Frame: at 8 and 12 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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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): NCT00978913


Locations
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Denmark
Department of Oncology, Herlev University Hospital
Herlev, Denmark, Dk 2730
Sponsors and Collaborators
Inge Marie Svane
Investigators
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Study Director: Inge Marie Svane, prof.MD Department of Oncology, Herlev University Hospital, Herlev Ringvej 75,2730 Herlev
More Information
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Responsible Party: Inge Marie Svane, Professor, MD, Herlev Hospital
ClinicalTrials.gov Identifier: NCT00978913    
Other Study ID Numbers: AA 0914
First Posted: September 17, 2009    Key Record Dates
Last Update Posted: August 19, 2015
Last Verified: August 2015
Keywords provided by Inge Marie Svane, Herlev Hospital:
dendritic cell
cancervaccine
breast cancer
malignant melanoma
Cyclophosphamide
Additional relevant MeSH terms:
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Breast Neoplasms
Melanoma
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas
 Cyclophosphamide
Vaccines
Immunologic Factors
Physiological Effects of Drugs
Immunosuppressive Agents
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists