Myeloid and plasmacytoid blood dendritic cells for immunotherapy of stage III melanoma patients

Completed

Conditions: malignant melanoma
10040900

Registration Number: NL-OMON42306

Lead Sponsor: Tumor Immunologie

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 30

Inclusion Criteria

- stage III melanoma according to the 2009 AJCC criteria
- cytological or histological documented evidence of stage III melanoma
- WHO performance status 0-1 (Karnofsky 100-70) (Appendix 1)
- life expectancy *3 months
- age 18-75 years
- WBC >3.0×109/l, lymphocytes >0.8×109/l, platelets >100×109/l,
serum creatinine <150 µmol/l, serum bilirubin <25 µmol/l
- normal serum LDH (*250 U/l)
- expected adequacy of follow-up
- no pregnant or lactating women
- written informed consent

Exclusion Criteria

- irresectable stage III melanoma or stage IV melanoma
- any concurrent adjuvant therapy
- history of any second malignancy in the previous 5 years, with the exception of adequately treated basal cell carcinoma or carcinoma in situ of the cervix
- serious active infections, known HbsAg or HIV positive, or autoimmune diseases or organ allografts
- concomitant use of oral immunosuppressive drugs
- known allergy to shell fish (since it contains KLH)
- any serious clinical condition that may interfere with the safe administration of DC or apheresis

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary objective is the immunogenicity of single and combined pDC and mDC<br /><br>vaccination.<br /><br><br /><br>Immunogenicity is defined as the antitumor immune response induced in stage III<br /><br>melanoma patients. Therefore, immunomonitoring will be performed that includes:<br /><br><br /><br>1) Type I IFN gene expression in PBMC shortly after vaccination. The occurrence<br /><br>of the type I IFN response in patients will be compared.<br /><br>2) Proliferative, effector cytokine- and humoral responses to keyhole limpet<br /><br>hemocyanin (KLH).The occurrence of the response will be compared.<br /><br>3) Functional response and tetramer analysis of DTH-infiltrating T cells<br /><br>against tumor peptides. The occurrence of the response will be compared. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The biodistribution, safety, quality of life and overall survival are secondary<br /><br>objectives.<br /><br><br /><br>Biodistribution is:<br /><br>(a) The migratory capacity of blood DC in vivo.<br /><br>(b) The localization of injected blood DC in dissected lymph nodes.</p><br>