Dendritic Cell Vaccination and Docetaxel for Patients With Prostate Cancer

NCT01446731 | Completed Phase 2 Results DMC

• 1 other identifier: UR1121
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 2

Brief 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 evaluated 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.

Conditions

Prostatic Neoplasms

Keywords

Prostate cancer

Outcome Measures

Primary Outcomes (1)

• Number of Patients With Immunological Response

  The induction of vaccine specific immune responses will be assessed using interferon-gamma ELISPOT assay

  2 years

Secondary Outcomes (3)

• Number of Patients With PSA Response

  2 years

• Number of Patients With Adverse Event Considered Related to the Dendritic Cell Vaccine

  2 years

• Progression-free Survival

  2 years

Study Arms (2)

Arm A

EXPERIMENTAL

DC vaccine (mRNA transfected dendritic cell) + Docetaxel

Biological: mRNA transfected dendritic cell; Drug: Docetaxel

Arm B

ACTIVE COMPARATOR

Docetaxel alone

Drug: Docetaxel

Interventions

mRNA transfected dendritic cell BIOLOGICAL

Autologous monocytes are matured into dendritic cells which are then transfected with mRNA from PSA, PAP, survivin and hTERT. 5x 10e6 DCs are given as intradermal injections in the groin Day 8 and Day 15 in a 3 week period repeated 4 times and thereafter Day 8 in a 3 week period until progression (no maximum duration).

Arm A

Docetaxel DRUG

Docetaxel 75 mg/m2 is given as an intravenous injection Day 1 every three weeks in a maximum of 12 cycles (1 cycle = 3 weeks).

Also known as: taxotere

Arm A; Arm B

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histological verified CRMPC in progression, defined by
• RECIST-criteria and/or
• PSA increase to more than baseline in two consecutive measurements
• Treatment with Docetaxel is indicated
• Age \> 18 years old
• ECOG performance status ≤2
• Life expectancy \> 3 months
• Normal organ function

You may not qualify if:

• Other malignant tumors
• Severe heard or lung disorders
• Infection with HIV, hepatitis, tuberculosis.
• Severe allergy or previous anaphylactic reactions
• Active autoimmune disease
• Treatment with immunosuppressive drugs (including prednisolon, methotrexate)7. Co-treatment with other experimental treatments, other antineoplastic treatment.

Sponsors & Collaborators

• Inge Marie Svane: lead

Study Sites (2)

Center for Cancer Immune Therapy, Dept. of Haematology/Oncology

Copenhagen, Herlev, 2730, Denmark

Location

Department of Oncology, Herlev Hospital

Herlev, 2730, Denmark

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Docetaxel

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Results Point of Contact

• Title: Per Kongsted, M.D.
• Organization: Center for Cancer ImmuneTherapy

per.kongsted@regionh.dk

+45 38689255

Study Officials

• Per Kongsted, MD

  CCIT / Department of Oncology, Herlev Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 2, 2011
• First Posted: October 5, 2011
• Study Start: October 1, 2011
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2015
• Last Updated: July 3, 2024
• Results First Posted: July 3, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

DK (2)