Immunotherapy for the treatment of prostate cancer

Phase 1

• Conditions: Prostate cancer; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2012-005498-29-SI
• Lead Sponsor: Celica, Biomedical Center, d.o.o.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-03-01
• Last Update Posted: 9 January 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Male
• Target Recruitment: Not specified

Inclusion Criteria

• Histologically proven prostate cancer in a progressive stage of disease despite castrate levels of testosterone
• Men of 18 years of age or older, who have signed an informed consent to participate in the trial
• Life expectancy at least 12 months (ECOG performance status 0-1)
• Positive DTH response on historical antigens
• Laboratory values as outlined in the protocol

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 2
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 18

Exclusion Criteria

• Active metastasis in the central nervous system
• Active infectious diseases that would require antibiotic or antivirus therapy
• Patients suffering from severe pain that would require chronic opioid analgesic therapy
• Patients who are HIV+, HBV+, or HCV+
• Serious intercurrent medically uncontrolled illness
• Intercurrent secondary malignant neoplasm
• Clinically significant vasculitis or other autoimmune disease
• Alcohol addiction or addiction to other drugs
• Psychiatric disorders that could affect the study
• Patients that received immunomodulatory therapy within 30 days prior to the initiation of the study
• Previous radiation therapy for prostate cancer
• Previous radical operative treatment of prostate
• Previous severe radiation therapy for lymph nodes
• Hydroxyurea treatment within 45 days prior to the initiation of the study
• Signs of toxicity of the previous therapies
• Patients treated with more than one chemotherapy cycle
• The last chemotherapy treatment less than 4 weeks prior to the initiation of the study
• Previous autologous or alogenic anti-tumor vaccine
• Intercurrent immune therapy or chemotherapy
• Corticosteroid treatment or other treatments of adrenal insufficiency within 2 weeks prior to the initiation of the study (hormonal therapy for the maintenance of the castrate levels of testosterone is allowed)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary end point(s): To assess safety, practicability, tolerability and non-toxicity of the treatment with autologous immunohybridoma cells and the effect on the quality of live of the patients with prostate cancer<br><br> ;Timepoint(s) of evaluation of this end point: 6 months from the initiation of the study for each patient;Main Objective: To assess safety, practicability, tolerability and non-toxicity of the treatment with autologous immunohybridoma cells and the effect on the quality of live of the patients with prostate cancer;Secondary Objective: To asses the type and the extend of the clinical outcome of the treatment with autologous immunohybridoma cells and to evaluate the effect on the overall survival of the patient with prostate cancer

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): To determine if cellular immunity is induced by consecutive vaccinations with autologous immunohybridoma cells in prostate cancer patients.<br><br>To determine if vaccination with autologous immunohybridoma cells results in clinically measurable disease responses.;Timepoint(s) of evaluation of this end point: 1 year from the initiation of the study for each patient