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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental | diluted dinitrophenyl(DNP) Vaseline (which equaled to 2% DNP 0.1ml) was started to be directly spread on the surfaces of primary or metastatic tumors of malignant melanoma patients since the first day of every circle of chemotherapy, simultaneously laser irradiation was carried out for 10 min, the power density of laser irradiation was 1W/cm2. The tumors were wrapped and blocked for two days to induce contact dermatitis. If lymph nodes had been cleared, sensibilization of 2×2cm was performed at occipital region. It was repeated once a week. |
| |
| Control | only diluted DNP Vaseline was spread and the operation were the same with the treatment group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| dinitrophenyl(DNP) | Drug |
| ||
| Radiation |
| Measure | Description | Time Frame |
|---|---|---|
| ORR | Patients who have complete regression or partial regression | 6 weeks after administration whose achieve CR and PR |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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Inclusion Criteria:
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patients with stage III (b or c) or stage IV skin (which could not be excised by operations) malignant melanoma
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| Name | Affiliation | Role |
|---|---|---|
| Nan Du, PHD | First Affiliated Hospital, Chinese PLA General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| First Affiliated Hospital, Chinese PLA General Hospital | Beijing | Beijing Municipality | 100048 | China |
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| ID | Term |
|---|---|
| D008545 | Melanoma |
| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| D011827 | Radiation |
| ID | Term |
|---|---|
| D055585 | Physical Phenomena |
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laser irradiation was carried out for 10 min, the power density of laser irradiation was 1W/cm2 |
|
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 |
| D009369 | Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
| D009371 | Neoplasms by Site |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |