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

Myeloid and plasmacytoid blood dendritic cells for immunotherapy of stage III melanoma patients - myDC/pDC in stage III melanoma patients

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON42306

Enrollment

Registered

2014-06-16

Start date

2015-10-09

Completion date

Unknown

Last updated

2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

malignant melanoma

Interventions

Stage lll melanoma patients will receive pDC (arm A, n=7), myDC (arm B, n=7) or combined pDC/myDC (arm C, n=7). Subsequent vaccinations will be performed according to the protocol: 2 biweekly vaccin

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

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

Measure

Time frame

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

—

Secondary

Measure	Time frame
The biodistribution, safety, quality of life and overall survival are secondary objectives. Biodistribution is: (a) The migratory capacity of blood DC in vivo. (b) The localization of injected blood DC in dissected lymph nodes.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)