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

Chinese PLA General Hospital72 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Melanoma

Interventions

dinitrophenyl(DNP)DRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

ORR

Patients who have complete regression or partial regression

Time frame: 6 weeks after administration whose achieve CR and PR

Secondary Outcomes

PFS

Time frame: From enrollment to progression or death, which up to 2 years

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)

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