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

Phase 1

Completed

• Conditions: Breast Cancer; Malignant Melanoma
• Interventions: Biological: DC vaccine

• Registration Number: NCT00978913
• Lead Sponsor: Inge Marie Svane

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).

Study Timeline

• Study Start: 2009-09
• Study First Submitted: 2009-09-16
• Study First Submitted QC: 2009-09-16
• Study First Posted: 2009-09-17
• Primary Completion: 2013-08
• Study Completion: 2014-05
• Status Verified: 2015-08
• Last Update Submitted: 2015-08-18
• Last Update Posted: 2015-08-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 31

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

10. 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
DC vaccination and Cyclophosphamide	DC vaccine	-

Primary Outcome Measures

Name	Time	Method
to evaluate the toxicity of the vaccine in combination with Cyclophosphamide	biweekly

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Department of Oncology, Herlev University Hospital; 🇩🇰 Herlev, Denmark