Status:
COMPLETED
Transfected Dendritic Cell Based Therapy for Patients With Breast Cancer or Malignant Melanoma
Lead Sponsor:
Inge Marie Svane
Conditions:
Breast Cancer
Malignant Melanoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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 second...
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 ...
Eligibility Criteria
Inclusion
- Histological verified metastatic breast cancer or malignant melanoma, in progression
- ≥ 18 years
- the patient must be habil
- Performance status ≤ 1 on Zubrod-ECOG-WHO-scale
- Leukocytes and platelets must be ≥normal. Hg ≥ 6.0
- creatinin must be normal
- Liverparametre \<2.5 x normal. Bilirubin \<30
- Expected survival \> 3 months
- Informed consent
- 11\. At least one measurable lesion according to RECIST criteria.
Exclusion
- Indication for chemotherapy
- Other malignancies
- Brain metastases
- severe medical condition
- Acute/chronic infection with ex. HIV, hepatitis, tuberculose
- Severe allergy
- Autoimmune disease
- Other treatment with immune suppressing agents, other anticancer agents or experimental drugs
- Uncontrolled hypercalcemia.
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2014
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT00978913
Start Date
September 1 2009
End Date
May 1 2014
Last Update
August 19 2015
Active Locations (1)
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1
Department of Oncology, Herlev University Hospital
Herlev, Denmark, Dk 2730