Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00026143
Status:
COMPLETED
Last Update Posted:
2013-06-05
First Post:
2001-11-09
Brief Title:
Interleukin-12 and Interferon Alfa in Treating Patients With Metastatic Malignant Melanoma
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase II Trial of Interleukin-12 NSC 672423 IND 6798 Followed by Interferon Alfa-2B in Patients With Metastatic Malignant Melanoma
Status:
COMPLETED
Status Verified Date:
2013-06
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 combining interleukin-12 and interferon alfa in treating patients who have metastatic malignant melanoma 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 Interferon alfa may interfere with the growth of the cancer cells Combining interleukin-12 and interferon alfa may kill more tumor cells
Detailed Description:
PRIMARY OBJECTIVES
I To estimate the clinical response rates in patients with metastatic malignant melanoma treated with rhIL-12 and interferon alfa-2b
II To estimate the progression-free survival in patients with metastatic malignant melanoma treated with rhIL-12 and interferon alfa-2b
SECONDARY OBJECTIVES
I To measure serum levels of interferon-gamma II To measure levels of JAK-STAT signaling intermediates in patient PBMCs and tumor samples
III To analyze interferon-alpha-induced STAT signaling in patient PBMCs IV To determine the expression of IFN-regulated genes in patient PBMCs and tumor tissues
V To determine the pattern of gene expression induced by treatment with IL-12 and interferon-alpha using DNA microarray techniques in patient PBMCs
OUTLINE This is a multicenter study
Patients receive interleukin-12 IV over 5-15 seconds on day 1 and interferon alfa subcutaneously on days 2-6 Treatment repeats every 2 weeks in the absence of unacceptable toxicity Patients are reassessed after 6 courses Patients with a complete response receive 2 additional courses Patients with a partial response or stable disease continue treatment in the absence of disease progression
Patients are followed every 3 months for 1 year and then every 6 months for 1 year
I To estimate the clinical response rates in patients with metastatic malignant melanoma treated with rhIL-12 and interferon alfa-2b
II To estimate the progression-free survival in patients with metastatic malignant melanoma treated with rhIL-12 and interferon alfa-2b
SECONDARY OBJECTIVES
I To measure serum levels of interferon-gamma II To measure levels of JAK-STAT signaling intermediates in patient PBMCs and tumor samples
III To analyze interferon-alpha-induced STAT signaling in patient PBMCs IV To determine the expression of IFN-regulated genes in patient PBMCs and tumor tissues
V To determine the pattern of gene expression induced by treatment with IL-12 and interferon-alpha using DNA microarray techniques in patient PBMCs
OUTLINE This is a multicenter study
Patients receive interleukin-12 IV over 5-15 seconds on day 1 and interferon alfa subcutaneously on days 2-6 Treatment repeats every 2 weeks in the absence of unacceptable toxicity Patients are reassessed after 6 courses Patients with a complete response receive 2 additional courses Patients with a partial response or stable disease continue treatment in the absence of disease progression
Patients are followed every 3 months for 1 year and then every 6 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 |
|---|---|---|---|
| U10CA031946 | NIH | None | httpsreporternihgovquickSearchU10CA031946 |
| CALGB-500001 | None | None | None |
| CDR0000068990 | None | None | None |