Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00016289
Status:
COMPLETED
Last Update Posted:
2013-01-23
First Post:
2001-05-06
Brief Title:
Interleukin-12 in Treating Patients With Ovarian Epithelial Cancer or Primary Peritoneal Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
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
Status:
COMPLETED
Status Verified Date:
2013-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 persons 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
VI Determine whether this regimen facilitates adaptive or innate immunity in vivo or serum antibody responses to tumor-associated antigens in these patients
VII 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
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
VI Determine whether this regimen facilitates adaptive or innate immunity in vivo or serum antibody responses to tumor-associated antigens in these patients
VII 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| MDA-ID-00232 | None | None | None |
| N01CM17003 | NIH | None | None |
| CDR0000068619 | REGISTRY | PDQ Physician Data Query | httpsreporternihgovquickSearchN01CM17003 |