Finding studies
Finding studies
Take this into the appointment.
Saves the questions and what to expect into your notes, next to the visit they belong to.
Lead
National Cancer Institute (NCI)
OBJECTIVES: I. Determine the response rate (complete and partial) in patients with mycosis fungoides treated with interleukin-12 (IL-12). II. Determine the frequency of refractory disease in patients treated with this drug. III. Determine the toxic effects of this drug in these patients. IV. Determine the feasibility and dose-limiting toxic effects (DLT) of interleukin-2 (IL-2) when administered with IL-12 in patients who have not shown disease progression after 12 weeks of IL-12 and in those who have shown disease progression after 12 weeks of IL-12. V. Determine the maximum tolerated dose and recommended dose of IL-2 when administered with IL-12 in these patients. VI. Determine immune and cytokine response over time in patients treated with this regimen. VII. Determine the frequency of improved clinical response in patients treated with this regimen. VIII. Determine the biologic correlates of response, including levels of interferon gamma production, natural killer cell activity, infiltration of skin lesions by CD8-positive cells, lymphocyte IL-12 receptor expression, signal transducers and activators of transcription protein levels and IL-12 signal transduction, and induction of apoptosis in tumor cells in the skin of patients treated with this regimen. OUTLINE: This is an open-label, multicenter, dose-escalation study of interleukin-2 (IL-2). Patients receive interleukin-12 (IL-12) subcutaneously (SC) twice weekly for 24 weeks. Disease is assessed at 13 weeks. Patients who do not have progressive disease also receive IL-2 SC 3 consecutive days a week during weeks 13-24. Patients with progressive disease at week 13 receive IL-2 SC at a fixed dose during weeks 13-24. Patients with responding disease after week 24 may continue to receive IL-2 and IL-12 for another 12 weeks. Cohorts of 3-6 patients receive escalating doses of IL-2 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. The recommended dose (RD) is the dose preceding the MTD. Additional patients are treated at the RD. Patients are followed at 6 months. PROJECTED ACCRUAL: A total of 18-46 patients will be accrued for this study within 28 months.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
