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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

Tracking Information
First Submitted Date  ICMJE September 16, 2009
First Posted Date  ICMJE September 17, 2009
Last Update Posted Date August 19, 2015
Study Start Date  ICMJE September 2009
Actual Primary Completion Date August 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 3, 2011)
to evaluate the toxicity of the vaccine in combination with Cyclophosphamide [ Time Frame: biweekly ]
Original Primary Outcome Measures  ICMJE
 (submitted: September 16, 2009)
  • to evaluate the toxicity of the vaccine and the combination of the vaccine and Cyclophosphamide [ Time Frame: weeks ]
  • to evaluate the immune response induced by the vaccine [ Time Frame: weeks ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 3, 2011)
  • to investigate the clinical tumor response and the duration [ Time Frame: after 12 weeks ]
  • to evaluate the duration of tumor and immunoresponse [ Time Frame: 3, 6, 9 months ]
  • to evaluate immune response [ Time Frame: at 8 and 12 weeks ]
Original Secondary Outcome Measures  ICMJE
 (submitted: September 16, 2009)
  • to investigate the clinical tumor response and the duration [ Time Frame: weeks ]
  • to evaluate the duration of tumor and immunoresponse [ Time Frame: months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Transfected Dendritic Cell Based Therapy for Patients With Breast Cancer or Malignant Melanoma
Official Title  ICMJE Evaluation of Dendritic Cells Transfected With Survivin, hTERT and p53 mRNA as a Treatment for Patients With Metastatic Breast Cancer or Malignant Melanoma
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Breast Cancer
  • Malignant Melanoma
Intervention  ICMJE Biological: DC vaccine
DC vaccination, one vaccine biweekly
Other Names:
  • dendritic cell vaccine
  • Cyclophosphamide, Sendoxan®, Baxter
Study Arms  ICMJE Experimental: DC vaccination and Cyclophosphamide
Intervention: Biological: DC vaccine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 17, 2015)
31
Original Estimated Enrollment  ICMJE
 (submitted: September 16, 2009)
14
Actual Study Completion Date  ICMJE May 2014
Actual Primary Completion Date August 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Denmark
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00978913
Other Study ID Numbers  ICMJE AA 0914
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Inge Marie Svane, Herlev Hospital
Study Sponsor  ICMJE Inge Marie Svane
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Inge Marie Svane, prof.MD Department of Oncology, Herlev University Hospital, Herlev Ringvej 75,2730 Herlev
PRS Account Herlev Hospital
Verification Date August 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP