Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003439
Status:
COMPLETED
Last Update Posted:
2013-02-07
First Post:
1999-11-01
Brief Title:
Interleukin-12 in Treating Patients With Refractory Advanced-Stage Ovarian Cancer or Abdominal Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase I Dose-Escalating Study of Recombinant Human Interleukin-12 NSC 672423 Administered by Intraperitoneal Infusion in Refractory Advanced Stage Ovarian Cancer and Other Abdominal Carcinomatosis
Status:
COMPLETED
Status Verified Date:
2007-04
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 I trial to study the effectiveness of interleukin-12 in treating patients with refractory ovarian or abdominal cancers Interleukin-12 may kill tumor cells by stopping blood flow to the tumor and by stimulating a personss white blood cells to kill cancer cells
Detailed Description:
OBJECTIVES
I Assess the safety and maximum tolerated dose of recombinant human interleukin-12 rhIL-12 administered by intraperitoneal infusion in patients with chemotherapy refractory advanced ovarian cancer and other diffuse abdominal carcinomatosis
II Determine the immunopharmacologic profile of rhIL-12 in this patient population
III Evaluate the biologic response in selected patients to rhIL-12 administered through intraperitoneal infusions
OUTLINE This is a dose escalation multicenter study
Cohorts of 3-6 patients each receive escalating doses of intraperitoneal recombinant human interleukin-12 rhIL-12 administered weekly for 9 weeks If a patient tolerates rhIL-12 and shows evidence of objective response or stable disease patient may receive up to 9 additional weeks of treatment Treatment continues in the absence of unacceptable toxicity or disease progression Dose escalation continues until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which no more than 1 of 6 patients experiences dose limiting toxicity
All patients are followed for survival
I Assess the safety and maximum tolerated dose of recombinant human interleukin-12 rhIL-12 administered by intraperitoneal infusion in patients with chemotherapy refractory advanced ovarian cancer and other diffuse abdominal carcinomatosis
II Determine the immunopharmacologic profile of rhIL-12 in this patient population
III Evaluate the biologic response in selected patients to rhIL-12 administered through intraperitoneal infusions
OUTLINE This is a dose escalation multicenter study
Cohorts of 3-6 patients each receive escalating doses of intraperitoneal recombinant human interleukin-12 rhIL-12 administered weekly for 9 weeks If a patient tolerates rhIL-12 and shows evidence of objective response or stable disease patient may receive up to 9 additional weeks of treatment Treatment continues in the absence of unacceptable toxicity or disease progression Dose escalation continues until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which no more than 1 of 6 patients experiences dose limiting toxicity
All patients are followed for survival
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 |
|---|---|---|---|
| CDR0000066467 | REGISTRY | PDQ Physician Data Query | None |
| PCI-98-031 | None | None | None |
| PCI-MWH-97-039 | None | None | None |
| NCI-T97-0031 | None | None | None |