A Phase II Study of Recombinant Human Interleukin-12 (rhIL-12) for the Treatment of Relapsed Lymphoma and Hodgkin's Disease
I. Determine the response rate of interleukin-12 in previously treated patients with
non-Hodgkin's lymphoma or Hodgkin's disease.
II. To determine the in vivo regulatory effect of interleukin-12 on Fas lingand (FasL)
expression on patients' peripheral blood lymphocytes.
OUTLINE: Patients are stratified according to disease characteristics: low grade
non-Hodgkin's lymphoma (follicular small cleaved, follicular mixed, small lymphocytic, and
variants) versus intermediate grade non-Hodgkin's lymphoma (follicular large, diffuse large,
diffuse mixed, immunoblastic, peripheral T-cell, and mantle cell) versus Hodgkin's disease.
Patients receive interleukin-12 subcutaneously twice a week. Treatment repeats every 3 weeks
in the absence of disease progression or unacceptable toxicity.
PROJECTED ACCRUAL: A total of 36-105 patients will be accrued for this study.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Simon's two-stage model will be used.
Up to 5 years
M.D. Anderson Cancer Center
United States: Food and Drug Administration
|M D Anderson Cancer Center||Houston, Texas 77030|