Metastatic Cancer Clinical Trial
Official title:
Treament of Spontaneous Tumor Metastases With IL-12 DNA (NSC #709933): A Phase IB Trial
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.
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.
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