Autologous Dendritic Cell Therapy for Hormone-Refractory Metastatic Prostate Cancer

Phase 1

Completed

• Conditions: Prostatic Cancer

• Registration Number: NCT01171729
• Lead Sponsor: Samsung Medical Center

Brief Summary

This is an open label, Phase I/IIa trial of immunotherapy with CreaVax-PC as treatment in men with hormone-Refractory Metastatic Prostate Cancer.

Detailed Description

CreaVax-PC consisted of antigen (PSA, PAP and KLH) primed dendritic cell is an investigational product designed to activate a man's immune response, so they can detect prostate cancer cells and initiate an immune response against prostate cancer antigens.

If patients decide to participate and are eligible, they will be enrolled in the study and will receive active product (CreaVax-PC). In detail, patients will receive CreaVax-PC injection at intervals of 3 weeks, maximum 6 times during 21 weeks. PSA increase rate is a primary evaluation variables and tumor suppression effect is secondary evaluation variables. We also evaluate time to progression, overall survival and immune response.

Study Timeline

• Study Start: 2006-07
• Primary Completion: 2010-05
• Study Completion: 2010-05
• Status Verified: 2010-07
• Study First Submitted: 2010-07-27
• Study First Submitted QC: 2010-07-27
• Study First Posted: 2010-07-28
• Last Update Submitted: 2010-08-10
• Last Update Posted: 2010-08-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 12

Inclusion Criteria

• 1. Histological confirmed prostatic carcinoma patient
• 2. Hormone non-respondence ex1) Although treatment PSA ≥ 5ng/ml ex2) PSA level were measured two times ex3) Prior one year radiology were processed
• 3. Just 18 years over
• 4. Has a score ≤1 on the ECOG Performance Scale
• 5. Expected survival life time ≥ 6month
• 6. Adequate bone marrow function hemoglobin ≥ 10.0g/dL , leukocyte count ≥ 4,000/mm3 thrombocyte ≥ 100,000/mm3
• 7. Adequate blood coagulation function PT(INR) < 1.5, aPTT< 1.5 x control
• 8. Adequate kidney function Normal blood upper level Creatinine ≤ 1.5 times
• 9. Adequate liver function Normal blood upper level AST/ALT ≤ 1.5 times
• 10. Autoimmune antibody system don't have disorder ex) anti-nuclear antibody, anti-thyroglobulin antibody negativity
• 11. Person who didn't treat prior 6 weeks operation, radiotherapy treatment,immunotherapy or chemotherapy
• 12. Patient who voluntarily participated clinical trial and confirmed a written consent

Exclusion Criteria

• 1. Having other malignancy or previous history of malignancy
• 2. Brain metastases patient
• 3. Having autoimmune disease or its history
• 4. Pyrexia, rigor, leukocytosis infectious disease
• 5. HBsAg, anti-HCV, HIV positive patient
• 6. Myocardial infarction, cardiac insufficiency, other severe heart disease and non-controlled hypertension
• 7. Severe and active medical disease
• 8. Mental history disease or epilepsy
• 9. Patients participated other clinical trial within 4 weeks
• 10. Patients impossible to participate this trial by investigator's decision
• 11. Patients who received immunosuppressant such as steroid, cyclosporin A, azathioprine within 6 weeks

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
PSA increment and absolute PSA response	12 weeks	PSA response evaluation at 12 weeks and follow up response evaluation at 21 weeks

Secondary Outcome Measures

Name	Time	Method
Time to Progression	DC Injection to time to progression or death
Overall Survival	Patients will be followed until death
Immune Response(DTH response, Interferon-gamma Elispot assay, proliferation assay, ELISA)	weeks 0, 12, 21
Clinical response	week 0, 12, 21	Clinical course of participants as measured by bone scans and CT

Trial Locations

Locations (2)

National Cancer Center; 🇰🇷 Gyeonggi-do, 323 Ilsan-ro Ilsandong-gu Goyang-si, Korea, Republic of

Samsung Medical Center; 🇰🇷 Seoul, Gangnam-Gu, Ilwon-Dong, Korea, Republic of