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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2010 by Herlev Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Herlev Hospital
ClinicalTrials.gov Identifier:
NCT00978913
First received: September 16, 2009
Last updated: October 3, 2011
Last verified: March 2010
History of Changes

September 16, 2009
October 3, 2011
September 2009
September 2012   (final data collection date for primary outcome measure)
to evaluate the toxicity of the vaccine in combination with Cyclophosphamide [ Time Frame: biweekly ] [ Designated as safety issue: Yes ]
  • to evaluate the toxicity of the vaccine and the combination of the vaccine and Cyclophosphamide [ Time Frame: weeks ] [ Designated as safety issue: Yes ]
  • to evaluate the immune response induced by the vaccine [ Time Frame: weeks ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00978913 on ClinicalTrials.gov Archive Site
  • 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 ]
  • to investigate the clinical tumor response and the duration [ Time Frame: weeks ] [ Designated as safety issue: No ]
  • to evaluate the duration of tumor and immunoresponse [ Time Frame: months ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Transfected Dendritic Cell Based Therapy for Patients With Breast Cancer or Malignant Melanoma
Evaluation of Dendritic Cells Transfected With Survivin, hTERT and p53 mRNA as a Treatment for Patients With Metastatic Breast Cancer or Malignant Melanoma

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.

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).
Interventional
Phase 1
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Breast Cancer
  • Malignant Melanoma
Biological: DC vaccine
DC vaccination, one vaccine biweekly
Other Names:
  • dendritic cell vaccine
  • Cyclophosphamide, Sendoxan®, Baxter
Experimental: DC vaccination and Cyclophosphamide
Intervention: Biological: DC vaccine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
14
September 2012
September 2012   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact: Inge Marie Svane, prof.MD +4544884488 imsv@heh.regionh.dk
Contact: Lotte Engell-Nørregård, MD +4544884488 loteng02@heh.regionh.dk
Denmark
 
NCT00978913
AA 0914
Yes
Inge Marie Svane prof. MD, Department of oncology, Herlev Hospital
Herlev Hospital
Not Provided
Study Director: Inge Marie Svane, prof.MD Department of Oncology, Herlev University Hospital, Herlev Ringvej 75,2730 Herlev
Herlev Hospital
March 2010

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