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
Mayo Clinic
With
OBJECTIVES: I. Determine the optimal immunological dose of interleukin-12 and rituximab when administered in combination in patients with non-Hodgkin's lymphoma. II. Determine the toxicities associated with this regimen in this patient population. III. Assess the pharmacodynamics of this regimen in these patients. IV. Document observed clinical response to this regimen in these patients. OUTLINE: This is a dose escalation study of interleukin-12. Patients receive rituximab IV on days 1, 8, 15, and 22. The first cohort of patients receives interleukin-12 SC twice weekly beginning on day 29. Subsequent cohorts receive interleukin-12 SC twice weekly beginning on day 16. Patients with stable or responding disease may continue treatment with interleukin-12 twice weekly for up to 24 weeks or until disease progression. Cohorts of 6-9 patients receive escalating doses of interleukin-12 until the optimal immunological dose is determined. The optimal immunological dose is defined as the dose preceding that at which 2 of 6 or 2 of 9 patients experience dose limiting toxicities or the dose at which there is a maximal increase in gamma interferon, inducible protein-10 (IP-10) and immune cell infiltration into the lymphoma (whichever dose is lower). Following initial dose escalation, 2 additional cohorts of 6 patients receive a fixed dose of interleukin-12 SC twice weekly beginning on day 2. Patients are followed every 3 months for the first year, and then every 6 months for the next 4 years or until disease progression. PROJECTED ACCRUAL: A maximum of 45 patients will be accrued for this study within 12-13 months.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
