Ignite Creation Date:
2024-05-05 @ 9:36 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003046
Status:
COMPLETED
Last Update Posted:
2012-07-30
First Post:
1999-11-01
Brief Title:
Interleukin-12 in Treating Patients With Cancer in the Abdomen
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
Phase I Study of Intraperitoneal Recombinant Human Interleukin-12 rhIL-12 in Patients With Peritoneal Carcinomatosis Associated With Mullerian and Gastrointestinal Carcinomas
Status:
COMPLETED
Status Verified Date:
2012-07
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:
RATIONALE Interleukin-12 may kill tumor cells by stimulating a persons white blood cells to kill cancer cells
PURPOSE Phase I trial to study the effectiveness of interleukin-12 in treating patients with cancer in the abdomen
PURPOSE Phase I trial to study the effectiveness of interleukin-12 in treating patients with cancer in the abdomen
Detailed Description:
OBJECTIVES I Determine the maximum tolerated dose of intraperitoneal interleukin-12 in patients with Mullerian carcinoma closed to accrual as of 82301 gastrointestinal carcinoma or peritoneal mesothelioma closed to accrual as of 82301 II Determine the qualitative and quantitative toxicity and reversibility of toxicity of this regimen in these patients
OUTLINE This is a dose-escalation multicenter study Patients receive intraperitoneal interleukin-12 over 30 minutes once weekly for 4 weeks Treatment repeats every 4 weeks for up to 6 courses in the absence of unacceptable toxicity or disease progression Patients with stable or responsive disease may receive an additional 6 courses Patients receive escalating doses of intraperitoneal interleukin-12 until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity Once the MTD is established additional patients are accrued to receive interleukin-12 at the recommended dose
PROJECTED ACCRUAL Approximately 20-40 patients will be accrued for this study within 2 years
OUTLINE This is a dose-escalation multicenter study Patients receive intraperitoneal interleukin-12 over 30 minutes once weekly for 4 weeks Treatment repeats every 4 weeks for up to 6 courses in the absence of unacceptable toxicity or disease progression Patients with stable or responsive disease may receive an additional 6 courses Patients receive escalating doses of intraperitoneal interleukin-12 until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity Once the MTD is established additional patients are accrued to receive interleukin-12 at the recommended dose
PROJECTED ACCRUAL Approximately 20-40 patients will be accrued for this study within 2 years
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 |
|---|---|---|---|
| CDR0000065681 | REGISTRY | NCI PDQ | httpsreporternihgovquickSearchP30CA016672 |
| P30CA016672 | NIH | None | None |
| NCI-T97-0034 | None | None | None |
| MDA-ID-97027 | OTHER | None | None |