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Trial of pIL-12 Electroporation Malignant Melanoma (IL12MEL)

Complete title: A Multicenter Phase II Trial of Intratumoral pIL-12 Electroporation in Advanced Stage Cutaneous and in Transit Malignant Melanoma

Research Study Number       7703
    
Principal Investigator       Shailender Bhatia, MD
    
Phase       II

Look up trial at NIH

Research Study Description

Study Title: A Multicenter Phase II trial of intratumoral pIL-12 electroporation in advanced stage cutaneous and in transit malignant melanoma

Design: Single-arm, open-label, multicenter Phase II interventional trial

Sample size: 25 evaluable subjects

Sample accrual: 10 per year

Population: Patients with AJCC stage IIIB, IIIC or IV M1a melanoma with cutaneous or in transit lesions accessible to electroporation

Regimen: One 8-day cycle of IL-12 plasmid, 0.5 mg/ml X 1ml intratumorally, with electroporation on days 1, 5, and 8. If there is evidence of persistent disease after 180 days (6 months) and no evidence of systemic progression, patients may be retreated every 3 months at the investigator's discretion. Otherwise, only 1 cycle of treatment will be given.

Objectives:

Primary:

- To determine the 24-week distant response rate (complete and partial) of patients with advanced cutaneous melanoma treated with IL-12 plasmid electroporation

Secondary:

- Local response rate

- Progression free survival

- Overall survival

- Duration of distant response

- Time to objective response

- Safety of intratumoral IL-12 in vivo electroporation

Exploratory:

- To describe the immunologic effects of IL-12 plasmid electroporation:

-- **Induction of intratumoral IL-12 and IFN-gamma within electroporated melanoma tumors

-- **Proportion of tumor-infilitrating lymphocyte subsets such as regulatory (FoxP3+) T cells at baseline and post-treatment

-- **Proportion of circulating lymphocyte subsets such as regulatory (FoxP3+) and effector (CD25+CD69+CD4+ and CD25+CD69+CD8+) T cells at baseline and post-treatment

-- **Antigen-specific cellular and humoral immune responses in peripheral blood at baseline and post-treatment and whether this is associated with clinical response

Eligibility Criteria (must meet the following to participate in this study)

** For Eligibility information, please click on the "Look up trial at NIH" link above. **

Other eligibility criteria may apply.



Research Study Number       7703
    
Contact       Seattle Cancer Care Alliance Intake Office
    
Telephone       800-804-8824 / 206-288-1024
    
   

Keywords
Melanoma; Skin Cancer; Solid Tumors

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