Interleukin-12 in Treating Patients With Ovarian Epithelial Cancer or Primary Peritoneal Cancer
Primary Peritoneal Cavity Cancer, Recurrent Ovarian Epithelial Cancer
About this trial
This is an interventional treatment trial for Primary Peritoneal Cavity Cancer
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
Sites / Locations
- M D Anderson Cancer Center
Arms of the Study
Arm 1
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.