Melanoma
Conditions
Brief summary
To evaluate the therapeutic efficacy and the safety for the treatments on malignant melanoma by combining semiantigen dinitrophenyl (DNP) in situ immunotherapy and laser therapy, and carry out monitoring on related immunological parameters of the patients. 72 patients with stage III (b or c) or stage IV skin (which could not be excised by operations) malignant melanoma were treated by combining simple semiantigen DNP in situ immunotherapy and laser therapy respectively. The changes in peripheral blood CD4+CD25+Treg regulatory T cells (Treg), CD8+T, CD4+ T effector cells, IL-10, TGF-β and other inhibitory cytokines of the patients were detected, the changes in anti-DNP IgG antibody titer was monitored, the relationship between delayed-type hypersensitivity (DTH) and survival was observed, and results of clinical follow-ups were also examined.
Interventions
DRUGdinitrophenyl(DNP)
RADIATIONRadiation
laser irradiation was carried out for 10 min, the power density of laser irradiation was 1W/cm2
Sponsors
Chinese PLA General Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* pathologically diagnosed as malignant melanoma, HMB45 (+～++++), S100 (+～++++); * Basically normal hepatic and renal functions as well as results for blood routine examinations; * Karnofsky score ≥ 60; * Anticipated life span for more than three months; * They were all malignant melanoma patients suffering from skin malignant melanoma of local or distal metastasis unsuitable for operations in their skin; * The therapeutic efficacy was objectively evaluated with reference to the criteria from WHO; * All of the subjects had signed the informed consent and had been submitted and approved by the ethic committee of the hospital, the compliance was good and follow-ups can be easily carried out.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| ORR | 6 weeks after administration whose achieve CR and PR | Patients who have complete regression or partial regression |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PFS | From enrollment to progression or death, which up to 2 years | — |
| OS | From enrollment to death, which up to 2 years | — |
| biomarker (peripheral blood CD4+CD25+Treg regulatory T cells (Treg), CD8+T, CD4+ T effector cells, IL-10, TGF-β) | day 0 and day 2,5,10,20 | peripheral blood CD4+CD25+Treg regulatory T cells (Treg), CD8+T, CD4+ T effector cells, IL-10, TGF-β |
Countries
China
Outcome results
None listed