OBJECTIVES:

• 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.
• Determine the qualitative and quantitative toxicity and reversibility of toxicity of this regimen in these patients.
• 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.
• Assess quality of life in patients treated with this regimen.
• Determine the pharmacology and pharmacokinetics of this drug in these patients.
• Determine whether this regimen facilitates adaptive or innate immunity in vivo or serum antibody responses to tumor-associated antigens in these patients.
• 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.

PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study within 1 year.

DISEASE CHARACTERISTICS:

• 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 extraabdominal or parenchymal disease
• No more than 6 weeks since prior primary chemotherapy

PATIENT CHARACTERISTICS:

Age:

• 18 and over

Performance status:

• Zubrod 0-1

Life expectancy:

• Not specified

Hematopoietic:

• Absolute granulocyte count greater than 1,500/mm^3
• Platelet count at least 100,000/mm^3
• Lymphocyte count greater than 600/mm^3

Hepatic:

• 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

Renal:

• Creatinine no greater than 1.5 mg/dL

Cardiovascular:

• No significant cardiac disease

Pulmonary:

• No significant pulmonary disease

Other:

• 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

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• No prior immunotherapy

Chemotherapy:

• See Disease Characteristics
• Recovered from prior chemotherapy
• No concurrent chemotherapy

Endocrine therapy:

• No chronic steroid therapy

Radiotherapy:

• No prior radiotherapy

Surgery:

• See Disease Characteristics
• Recovered from prior surgery
• At least 2 weeks since prior laparoscopy
• At least 4 weeks since prior laparotomy