Treament of Spontaneous Tumor Metastases With IL-12 DNA (NSC #709933): A Phase IB Trial
- Determine the safety and toxicity of interleukin-12 gene in patients with spontaneous
- 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
- 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
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
Primary Purpose: Treatment
David M. Mahvi, MD
University of Wisconsin, Madison
United States: Federal Government
|University of Wisconsin Comprehensive Cancer Center||Madison, Wisconsin 53792|