Clinical Trial: Interleukin-12 in Treating Patients With Ovarian Epithelial Cancer or Primary Peritoneal Cancer

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Phase II Study of Intraperitoneal Recombinant Human Interleukin-12 (rhIL-12) in Patients With Peritoneal Carcinomatosis (Residual Disease < 1cm) Associated With Ovarian Epithe

Brief Summary: Phase II trial to study the effectiveness of intraperitoneal interleukin-12 in treating patients who have ovarian epithelial cancer or primary peritoneal cancer. Interleukin-12 may kill tumor cells by stopping blood flow to the tumor and by stimulating a person's white blood cells to kill tumor cells. Giving interleukin-12 directly into the peritoneal cavity may kill cancer cells

Detailed Summary:

OBJECTIVES:

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 patient
Sponsor: National Cancer Institute (NCI)

Current Primary Outcome:

  • Rate of remission determined by laparoscopy or laparotomy [ Time Frame: Up to 2 years ]
    Tested using an exact test for a single binomial proportion
  • Toxicity graded using the NCI CTC version 3.0 [ Time Frame: Up to 2 years ]
    Evaluated for each dose level and each course of therapy.
  • Progression-free interval [ Time Frame: Up to 2 years ]


Original Primary Outcome:

Current Secondary Outcome:

Original Secondary Outcome:

Information By: National Cancer Institute (NCI)

Dates:
Date Received: May 6, 2001
Date Started: July 2001
Date Completion:
Last Updated: January 22, 2013
Last Verified: January 2013