Clinical trial NCT00016289: Interleukin-12 in Treating Patients With Ovarian Epithelial Cancer or Primary Peritoneal Cancer
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Primary Peritoneal Cavity Cancer
Recurrent Ovarian Epithelial Cancer
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2003-01-27
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 description: 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 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.

Eligibility criteria: Inclusion Criteria:

* Histologically confirmed peritoneal carcinomatosis associated with ovarian epithelial or primary peritoneal epithelial carcinoma

  * Surgically documented disease after prior platinum-based chemotherapy with or without surgery
  * Minimal residual disease, defined as metastases less than 1 cm in largest diameter
* No significant adhesions or symptoms of obstruction
* No extra-abdominal or parenchymal disease
* No more than 6 weeks since prior primary chemotherapy
* Performance status - Zubrod 0-1
* Absolute granulocyte count greater than 1,500/mm\^3
* Platelet count at least 100,000/mm\^3
* Lymphocyte count greater than 600/mm\^3
* Bilirubin no greater than 1.5 mg/dL
* SGOT or SGPT no greater than 2.5 times upper limit of normal
* Albumin at least 3.0 g/dL
* Hepatitis B and C negative
* Creatinine no greater than 1.5 mg/dL
* No significant cardiac disease
* No significant pulmonary disease
* No overt autoimmune disease
* No other malignancy within the past 10 years except squamous cell carcinoma in situ or basal cell skin cancer
* HIV negative
* Successful placement of peritoneal catheter
* No prior immunotherapy
* See Disease Characteristics
* Recovered from prior chemotherapy
* No concurrent chemotherapy
* No chronic steroid therapy
* No prior radiotherapy
* See Disease Characteristics
* Recovered from prior surgery
* At least 2 weeks since prior laparoscopy
* At least 4 weeks since prior laparotomy

Primary outcomes:
measure: Rate of remission determined by laparoscopy or laparotomy
timeFrame: Up to 2 years
measure: Toxicity graded using the NCI CTC version 3.0
timeFrame: Up to 2 years
measure: Progression-free interval
timeFrame: Up to 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Renato Lenzi
role: PRINCIPAL_INVESTIGATOR
References: