Clinical trial · Interventional
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
NCT00978913CI-TRIAL-00018876completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Malignant Melanoma | Melanoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| DC vaccine | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- DC vaccination and Cyclophosphamide
- interventionNames
- Biological: DC vaccine
Primary outcomes (1)
- measure
- to evaluate the toxicity of the vaccine in combination with Cyclophosphamide
- timeFrame
- biweekly
Secondary outcomes (3)
- measure
- to investigate the clinical tumor response and the duration
- timeFrame
- after 12 weeks
- measure
- to evaluate the duration of tumor and immunoresponse
- timeFrame
- 3, 6, 9 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.