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
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Rate of remission determined by laparoscopy or laparotomy
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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
Exclusion Criteria
- Not provided
Arms & Interventions
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.
Intervention: recombinant interleukin-12 (Biological)
Outcomes
Primary Outcomes
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
Secondary Outcomes
No secondary outcomes reported