Clinical Research on the Treatments on Advanced Malignant Melanoma by Combining in Situ Immunotherapy and Laser Therapy
NCT ID: NCT02372708
Last Updated: 2015-02-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
72 participants
OBSERVATIONAL
2008-08-31
2014-05-31
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
dinitrophenyl(DNP)
Radiation
laser irradiation was carried out for 10 min, the power density of laser irradiation was 1W/cm2
Control
only diluted DNP Vaseline was spread and the operation were the same with the treatment group
dinitrophenyl(DNP)
Interventions
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dinitrophenyl(DNP)
Radiation
laser irradiation was carried out for 10 min, the power density of laser irradiation was 1W/cm2
Eligibility Criteria
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Inclusion Criteria
* 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.
18 Years
70 Years
ALL
No
Sponsors
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Chinese PLA General Hospital
OTHER
Responsible Party
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DuNan
professor
Principal Investigators
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Nan Du, PHD
Role: PRINCIPAL_INVESTIGATOR
First Affiliated Hospital, Chinese PLA General Hospital
Locations
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First Affiliated Hospital, Chinese PLA General Hospital
Beijing, Beijing Municipality, China
Countries
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Other Identifiers
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ML125396
Identifier Type: -
Identifier Source: org_study_id
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