Clinical Research on the Treatments on Advanced Malignant Melanoma by Combining in Situ Immunotherapy and Laser Therapy
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02372708|
Recruitment Status : Completed
First Posted : February 26, 2015
Last Update Posted : February 26, 2015
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.
|Condition or disease||Intervention/treatment|
|Melanoma||Drug: dinitrophenyl(DNP) Radiation: Radiation|
|Study Type :||Observational|
|Actual Enrollment :||72 participants|
|Official Title:||Clinical Research on the Treatments on Advanced Malignant Melanoma by Combining in Situ Immunotherapy and Laser Therapy|
|Study Start Date :||August 2008|
|Actual Primary Completion Date :||May 2012|
|Actual Study Completion Date :||May 2014|
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.
laser irradiation was carried out for 10 min, the power density of laser irradiation was 1W/cm2
only diluted DNP Vaseline was spread and the operation were the same with the treatment group
- ORR [ Time Frame: 6 weeks after administration whose achieve CR and PR ]Patients who have complete regression or partial regression
- PFS [ Time Frame: From enrollment to progression or death, which up to 2 years ]
- OS [ Time Frame: 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) [ Time Frame: 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02372708
|First Affiliated Hospital, Chinese PLA General Hospital|
|Beijing, Beijing, China, 100048|
|Principal Investigator:||Nan Du, PHD||First Affiliated Hospital, Chinese PLA General Hospital|