Interleukin-12 in Treating Patients With Ovarian Epithelial Cancer or Primary Peritoneal Cancer
|Primary Peritoneal Cavity Cancer Recurrent Ovarian Epithelial Cancer||Biological: recombinant interleukin-12||Phase 2|
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||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|
- 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 ]
|Study Start Date:||July 2001|
|Primary Completion Date:||July 2007 (Final data collection date for primary outcome measure)|
Experimental: Treatment (recombinant interleukin-12)
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.
Biological: recombinant interleukin-12
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00016289
|United States, Texas|
|M D Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Renato Lenzi||M.D. Anderson Cancer Center|