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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
Sponsor:
Information provided by (Responsible Party):
DuNan, Chinese PLA General Hospital

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.


Condition or disease Intervention/treatment
Melanoma Drug: dinitrophenyl(DNP) Radiation: Radiation

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Study Type : Observational
Actual Enrollment : 72 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Melanoma
MedlinePlus related topics: Melanoma

Group/Cohort Intervention/treatment
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.
Drug: dinitrophenyl(DNP)
Radiation: 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
Drug: dinitrophenyl(DNP)



Primary Outcome Measures :
  1. ORR [ Time Frame: 6 weeks after administration whose achieve CR and PR ]
    Patients who have complete regression or partial regression


Secondary Outcome Measures :
  1. PFS [ Time Frame: From enrollment to progression or death, which up to 2 years ]
  2. OS [ Time Frame: From enrollment to death, which up to 2 years ]
  3. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patients with stage III (b or c) or stage IV skin (which could not be excised by operations) malignant melanoma
Criteria

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.

Information from the National Library of Medicine

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


Locations
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China, Beijing
First Affiliated Hospital, Chinese PLA General Hospital
Beijing, Beijing, China, 100048
Sponsors and Collaborators
Chinese PLA General Hospital
Investigators
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Principal Investigator: Nan Du, PHD First Affiliated Hospital, Chinese PLA General Hospital
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Responsible Party: DuNan, professor, Chinese PLA General Hospital
ClinicalTrials.gov Identifier: NCT02372708    
Other Study ID Numbers: ML125396
First Posted: February 26, 2015    Key Record Dates
Last Update Posted: February 26, 2015
Last Verified: February 2015
Additional relevant MeSH terms:
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Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas