Clinical Research on the Treatments on Advanced Malignant Melanoma by Combining in Situ Immunotherapy and Laser Therapy

Melanoma Clinical Trial

Official title:

Clinical Research on the Treatments on Advanced Malignant Melanoma by Combining in Situ Immunotherapy and Laser Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02372708
• Other study ID #: ML125396
• Status: Completed
• Phase: Phase 2
• First received: February 13, 2015
• Last updated: February 25, 2015
• Start date: August 2008
• Est. completion date: May 2014

Study information

• Verified date: February 2015
• Source: Chinese PLA General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: May 2014
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Melanoma

Intervention

Drug:
• dinitrophenyl(DNP)

Radiation:
• Radiation
laser irradiation was carried out for 10 min, the power density of laser irradiation was 1W/cm2

Locations

Country	Name	City	State
China	First Affiliated Hospital, Chinese PLA General Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Chinese PLA General Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ORR	Patients who have complete regression or partial regression	6 weeks after administration whose achieve CR and PR	No
Secondary	PFS		From enrollment to progression or death, which up to 2 years	No
Secondary	OS		From enrollment to death, which up to 2 years	No
Secondary	biomarker (peripheral blood CD4+CD25+Treg regulatory T cells (Treg), CD8+T, CD4+ T effector cells, IL-10, TGF-ß)	peripheral blood CD4+CD25+Treg regulatory T cells (Treg), CD8+T, CD4+ T effector cells, IL-10, TGF-ß	day 0 and day 2,5,10,20	No