Interleukin-12 in Treating Patients With Ovarian Epithelial Cancer or Primary Peritoneal Cancer
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
4 other identifiers
interventional
30
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 6, 2001
CompletedStudy Start
First participant enrolled
July 1, 2001
CompletedFirst Posted
Study publicly available on registry
January 27, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2007
CompletedJanuary 23, 2013
January 1, 2013
6 years
May 6, 2001
January 22, 2013
Conditions
Outcome Measures
Primary Outcomes (3)
Rate of remission determined by laparoscopy or laparotomy
Tested using an exact test for a single binomial proportion
Up to 2 years
Toxicity graded using the NCI CTC version 3.0
Evaluated for each dose level and each course of therapy.
Up to 2 years
Progression-free interval
Up to 2 years
Study Arms (1)
Treatment (recombinant interleukin-12)
EXPERIMENTALPatients 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.
Interventions
Given intraperitoneally
Eligibility Criteria
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
- +16 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
M D Anderson Cancer Center
Houston, Texas, 77030, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Renato Lenzi
M.D. Anderson Cancer Center
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 6, 2001
First Posted
January 27, 2003
Study Start
July 1, 2001
Primary Completion
July 1, 2007
Last Updated
January 23, 2013
Record last verified: 2013-01