Dendritic Cell Vaccination and Docetaxel for Patients With Prostate Cancer

• Status: Completed
• Trial end date: 2015-08-01
• Target enrollment: 0
• Participant gender: Male

Summary

This is a randomized phase II trial including 40 patients with castration resistant metastatic cancer prostate (CRMPC).

Patients will be randomized between treatment with a dendritic cell vaccine plus docetaxel and docetaxel alone.

The primary objective is to evaluate the vaccine specific immune response and patients will be evlauated with blood tests and DTH reactions during the treatment course.

Secondary objectives are to evaluate clinical response by objective response (RECIST-criteria, 18F-NaF-PET/CT scan), PSA response, pain response and finally we determine time to progression and overall survival.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Inge Marie Svane
• Treatments: Docetaxel

Criteria

Inclusion Criteria:

1. Histological verified CRMPC in progression, defined by

1. RECIST-criteria and/or

2. PSA increase to more than baseline in two consecutive measurements

2. Treatment with Docetaxel is indicated

3. Age > 18 years old

4. ECOG performance status ≤2

5. Life expectancy > 3 months

6. Normal organ function

Exclusion Criteria:

1. Other malignant tumors

2. Severe heard or lung disorders

3. Infection with HIV, hepatitis, tuberculosis.

4. Severe allergy or previous anaphylactic reactions

5. Active autoimmune disease

6. Treatment with immunosuppressive drugs (including prednisolon, methotrexat)7. Co-treatment with other experimental treatments, other antineoplastic treatment.