Interleukin-12 in Treating Patients With Ovarian Epithelial Cancer or Primary Peritoneal Cancer
Completed · Phase 2
Conditions studied: Primary Peritoneal Cavity Cancer, Recurrent Ovarian Epithelial Cancer
In brief
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
Key facts
- Study ID
- NCT00016289
- Run by
- National Cancer Institute (NCI)
- People needed
- 30
- Starts
- 2001-07-01
- Last updated by the study team
- 2013-01-23
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- 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
Where it is running
- M D Anderson Cancer Center — Houston, Texas, United States
Full record on ClinicalTrials.gov
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