Ignite Creation Date:
2024-05-05 @ 10:18 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003017
Status:
COMPLETED
Last Update Posted:
2013-06-21
First Post:
1999-11-01
Brief Title:
Interleukin-12 in Treating Patients With Advanced or Recurrent Cancer of the Cervix
Sponsor:
Eastern Cooperative Oncology Group
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase II Clinical Trial of Interleukin-12 in Patients With Advanced Recurrent or Inoperable Carcinoma of the Cervix
Status:
COMPLETED
Status Verified Date:
2004-07
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 stopping blood flow to the tumor and by stimulating a persons white blood cells to kill cancer cells in the cervix
PURPOSE Phase II trial to study the effectiveness of interleukin-12 in treating patients who have advanced or recurrent cancer of the cervix
PURPOSE Phase II trial to study the effectiveness of interleukin-12 in treating patients who have advanced or recurrent cancer of the cervix
Detailed Description:
OBJECTIVES I Determine the response rates duration of response and survival in women with advanced recurrent or inoperable cervical cancer treated with interleukin-12 II Determine the toxic effects of systemic interleukin-12 in these patients III Correlate response to therapy and survival with the presence or absence of human papilloma virus HPV and the specific subtype of HPV in these patients
OUTLINE Patients are stratified according to prior chemotherapy yes vs no Patients receive induction interleukin-12 IV over 5-20 seconds on day -13 and then daily on days 1-5 Treatment continues every 21 days in the absence of unacceptable toxicity or disease progression Patients are followed every 3 months for 2 years every 6 months for 3 years and then annually thereafter
PROJECTED ACCRUAL A total of 78 patients 39 per stratum will be accrued for this study within 26 months
OUTLINE Patients are stratified according to prior chemotherapy yes vs no Patients receive induction interleukin-12 IV over 5-20 seconds on day -13 and then daily on days 1-5 Treatment continues every 21 days in the absence of unacceptable toxicity or disease progression Patients are followed every 3 months for 2 years every 6 months for 3 years and then annually thereafter
PROJECTED ACCRUAL A total of 78 patients 39 per stratum will be accrued for this study within 26 months
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 |
|---|---|---|---|
| ECOG-E1E96 | None | None | None |