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

Breast Cancer Clinical Trial

Official title:

Evaluation of Dendritic Cells Transfected With Survivin, hTERT and p53 mRNA as a Treatment for Patients With Metastatic Breast Cancer or Malignant Melanoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00978913
• Other study ID #: AA 0914
• Status: Completed
• Phase: Phase 1
• First received: September 16, 2009
• Last updated: August 18, 2015
• Start date: September 2009
• Est. completion date: May 2014

Study information

• Verified date: August 2015
• Source: Herlev Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Medicines Agency
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: May 2014
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Malignant Melanoma
• Melanoma

Intervention

Biological:
• DC vaccine
DC vaccination, one vaccine biweekly

Locations

Country	Name	City	State
Denmark	Department of Oncology, Herlev University Hospital	Herlev

Sponsors (1)

Lead Sponsor	Collaborator
Inge Marie Svane

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	to evaluate the toxicity of the vaccine in combination with Cyclophosphamide		biweekly	Yes
Secondary	to investigate the clinical tumor response and the duration		after 12 weeks	No
Secondary	to evaluate the duration of tumor and immunoresponse		3, 6, 9 months	No
Secondary	to evaluate immune response		at 8 and 12 weeks	No