Spots Global Cancer Trial Database for Interleukin-12 Gene Therapy in Treating Patients With Skin Metastases

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Trial Identification

Brief Title: Interleukin-12 Gene Therapy in Treating Patients With Skin Metastases

Official Title: Treament of Spontaneous Tumor Metastases With IL-12 DNA (NSC #709933): A Phase IB Trial

Study ID: NCT00028652

Conditions

Metastatic Cancer

Interventions

interleukin-12 gene

Study Description

Brief Summary: RATIONALE: Inserting the gene for interleukin-12 into a person's skin tumor cells may make the body build an immune response to kill tumor cells. PURPOSE: Phase I trial to study the effectiveness of interleukin-12 gene therapy in treating patients who have skin metastases.

Detailed Description: OBJECTIVES: * Determine the safety and toxicity of interleukin-12 gene in patients with spontaneous skin metastases. * Determine the antitumor immune response in patients treated with this regimen. * Compare the toxicity of this regimen administered for 1 week vs 2 weeks in these patients. * Compare the local and systemic antitumor response in patients treated with this regimen administered for 1 week vs 2 weeks. OUTLINE: Patients are stratified according to number of tumor sites (1 vs 2 vs 3 or more). Patients are assigned to 1 of 2 treatment arms. * Group A: Patients receive interleukin-12 gene intratumorally over 5 minutes on days 1, 3, and 5. * Group B: Patients receive IL-12 gene intratumorally over 5 minutes on days 1, 3, 5, 8, 10, and 12. Patients with stable or responding disease may receive 1 subsequent course beginning on day 29. Patients are followed at 3, 6, and 12 months. PROJECTED ACCRUAL: A total of 12 patients (6 per treatment group) will be accrued for this study.