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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00978913

Enrollment

Registered

2009-09-17

Start date

2009-09-30

Completion date

2014-05-31

Last updated

2015-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer, Malignant Melanoma

Keywords

dendritic cell, cancervaccine, breast cancer, malignant melanoma, Cyclophosphamide

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).

Interventions

BIOLOGICALDC vaccine

DC vaccination, one vaccine biweekly

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
to evaluate the toxicity of the vaccine in combination with Cyclophosphamide	biweekly

Secondary

Measure	Time frame
to investigate the clinical tumor response and the duration	after 12 weeks
to evaluate the duration of tumor and immunoresponse	3, 6, 9 months
to evaluate immune response	at 8 and 12 weeks

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 25, 2026