Phase II Study of Intraperitoneal Recombinant Human Interleukin-12 (rhIL-12) in Patients With Peritoneal Carcinomatosis (Residual Disease < 1cm) Associated With Ovarian Epithelial Cancer or Primary Peritoneal Carcinoma
I. Determine the response rate and progression-free interval in patients with peritoneal
carcinomatosis associated with ovarian epithelial cancer or primary peritoneal carcinoma
treated with intraperitoneal interleukin-12.
II. Determine the qualitative and quantitative toxicity and reversibility of toxicity of
this regimen in these patients.
III. Determine peritoneal cavity tumor cell responses, in terms of negative cytology,
conversion of aneuploidy to diploidy, and apoptosis as evidence of therapeutic effect, in
patients treated with this regimen.
IV. Assess quality of life in patients treated with this regimen. V. Determine the
pharmacology and pharmacokinetics of this drug in these patients.
VI. Determine whether this regimen facilitates adaptive or innate immunity in vivo or serum
antibody responses to tumor-associated antigens in these patients.
VII. Determine whether this regimen decreases expression of vascular endothelial growth
factor, fibroblast growth factor 2, and interleukin-8 as surrogate markers of angiogenesis
and whether a decrease in marker expression is associated with clinical activity of this
drug in these patients.
OUTLINE: This is a multicenter study.
Patients receive interleukin-12 intraperitoneally once weekly. Treatment repeats every 4
weeks for 4 courses in the absence of disease progression or unacceptable toxicity. Patients
with stable or responding disease receive 2 additional courses. Quality of life is assessed
at baseline; prior to weeks 2, 4, 8, 12, and 16 of treatment; when patients are informed of
their disease response; and then 2 weeks later. Patients are followed every 2 months for 1
year and then every 3 months for 1 year.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Rate of remission determined by laparoscopy or laparotomy
Tested using an exact test for a single binomial proportion
Up to 2 years
M.D. Anderson Cancer Center
United States: Food and Drug Administration
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