Return to search results.
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|
Research Study Description
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.
- To determine the 24-week distant response rate (complete and partial) of patients with advanced cutaneous melanoma treated with IL-12 plasmid electroporation
- Local response rate
- Progression free survival
- Overall survival
- Duration of distant response
- Time to objective response
- Safety of intratumoral IL-12 in vivo electroporation
- 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)
Other eligibility criteria may apply.
Melanoma; Skin Cancer; Solid Tumors
Disclaimer: We update this information regularly. However, what you read today may not be completely up to date.