Clinical Research on the Treatments on Advanced Malignant Melanoma by Combining in Situ Immunotherapy and Laser Therapy
NCT02372708 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 72
Last updated 2015-02-26
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.
Conditions
Interventions
- DRUG
-
dinitrophenyl(DNP)
- RADIATION
-
Radiation
laser irradiation was carried out for 10 min, the power density of laser irradiation was 1W/cm2
Sponsors & Collaborators
-
Chinese PLA General Hospital
lead OTHER
Principal Investigators
-
Nan Du, PHD · First Affiliated Hospital, Chinese PLA General Hospital
Eligibility
- Min Age
- 18 Years
- Max Age
- 70 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2008-08-31
- Primary Completion
- 2012-05-31
- Completion
- 2014-05-31
Countries
- China
Study Locations
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