Evaluation of Dendritic Cells Transfected With Survivin, hTERT and p53 mRNA as a Treatment for Patients With Metastatic Breast Cancer or Malignant Melanoma
18 Years
N/A
Both
Breast Cancer, Malignant Melanoma
Trial Information
Evaluation of Dendritic Cells Transfected With Survivin, hTERT and p53 mRNA as a Treatment for Patients With Metastatic Breast Cancer or Malignant Melanoma
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).
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.
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
to evaluate the toxicity of the vaccine in combination with Cyclophosphamide
Outcome Time Frame:
biweekly
Safety Issue:
Yes
Principal Investigator
Inge Marie Svane, prof.MD
Investigator Role:
Study Director
Investigator Affiliation:
Department of Oncology, Herlev University Hospital, Herlev Ringvej 75,2730 Herlev
Authority:
Denmark: Danish Medicines Agency
Study ID:
AA 0914
NCT ID:
NCT00978913
Start Date:
September 2009
Completion Date:
September 2012
Related Keywords:
- Breast Cancer
- Malignant Melanoma
- dendritic cell
- cancervaccine
- breast cancer
- malignant melanoma
- Cyclophosphamide
- Breast Neoplasms
- Melanoma
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