Autologous Dendritic Cell Therapy for Hormone-Refractory Metastatic Prostate Cancer

NCT01171729 | Completed Phase 1 DMC

• 1 other identifier: 2006-10-030
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 2

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.

Conditions

Prostatic Cancer

Keywords

Prostate cancer; PSA; Hormone refractory prostatic cancer

Outcome Measures

Primary Outcomes (1)

• PSA increment and absolute PSA response

  PSA response evaluation at 12 weeks and follow up response evaluation at 21 weeks

  12 weeks

Secondary Outcomes (4)

• 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

Interventions

Autologous dendritic cell BIOLOGICAL

Autologous dendritic cells pulsed with prostate cancer antigen and KLH

Also known as: CreaVax-PC

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Samsung Medical Center: lead
• National Cancer Center, Korea: collaborator

Study Sites (2)

National Cancer Center

Gyeonggi-do, 323 Ilsan-ro Ilsandong-gu Goyang-si, 410-769, South Korea

Location

Samsung Medical Center

Seoul, Gangnam-Gu, Ilwon-Dong, 135-710, South Korea

Location

MeSH Terms

Conditions

Prostatic Neoplasms; Prostatic Neoplasms, Castration-Resistant

Condition Hierarchy (Ancestors)

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

Study Officials

• J C W, M.D,Ph.D

  Samsung Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 27, 2010
• First Posted: July 28, 2010
• Study Start: July 1, 2006
• Primary Completion: May 1, 2010
• Study Completion: May 1, 2010
• Last Updated: August 11, 2010

Record last verified: 2010-07

Locations

KR (2)