Autologous Dendritic Cell Therapy for Hormone-Refractory Metastatic Prostate Cancer

A Phase I/IIa Study of Autologous Cell-based Vaccine Therapy With CreaVax-PC in Hormone-Refractory Metastatic Prostate Cancer Patients With PSA Relapse to Evaluate the Safety and Efficacy

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

Study Overview

• Status: Completed
• Conditions: Prostatic Cancer
• Intervention / Treatment: Biological: Autologous dendritic cell

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 Type: Interventional
• Enrollment (Actual): 12
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • 323 Ilsan-ro Ilsandong-gu Goyang-si
    • Gyeonggi-do, 323 Ilsan-ro Ilsandong-gu Goyang-si, Korea, Republic of, 410-769
      • National Cancer Center
  • Gangnam-Gu, Ilwon-Dong
    • Seoul, Gangnam-Gu, Ilwon-Dong, Korea, Republic of, 135-710
      • Samsung Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PSA increment and absolute PSA response	PSA response evaluation at 12 weeks and follow up response evaluation at 21 weeks	12 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Samsung Medical Center
• Collaborators: National Cancer Center, Korea
• Investigators: Principal Investigator: J C W, M.D,Ph.D, Samsung Medical Center

Study record dates

Study Major Dates

• Study Start: July 1, 2006
• Primary Completion (ACTUAL): May 1, 2010
• Study Completion (ACTUAL): May 1, 2010

Study Registration Dates

• First Submitted: July 27, 2010
• First Submitted That Met QC Criteria: July 27, 2010
• First Posted (ESTIMATE): July 28, 2010

Study Record Updates

• Last Update Posted (ESTIMATE): August 11, 2010
• Last Update Submitted That Met QC Criteria: August 10, 2010
• Last Verified: July 1, 2010

More Information

Terms related to this study

• Keywords: PSA; Prostate cancer; Hormone refractory prostatic cancer
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms
• Other Study ID Numbers: 2006-10-030