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

NCT ID: NCT00978913

Last Updated: 2015-08-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 31 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-09-30
• Study Completion Date: 2014-05-31

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).

Conditions

Breast Cancer; Malignant Melanoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

DC vaccination and Cyclophosphamide

Group Type: EXPERIMENTAL

DC vaccine

Intervention Type: BIOLOGICAL

DC vaccination, one vaccine biweekly

Interventions

DC vaccine

DC vaccination, one vaccine biweekly

Intervention Type: BIOLOGICAL

Other Intervention Names

dendritic cell vaccine; Cyclophosphamide, Sendoxan®, Baxter

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Inge Marie Svane

OTHER

Sponsor Role: lead

Responsible Party

Inge Marie Svane

Professor, MD

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Inge Marie Svane, prof.MD

Role: STUDY_DIRECTOR

Department of Oncology, Herlev University Hospital, Herlev Ringvej 75,2730 Herlev

Locations

Department of Oncology, Herlev University Hospital

Herlev, , Denmark

Countries

Denmark

Other Identifiers

AA 0914

Identifier Type: -

Identifier Source: org_study_id