Ignite Creation Date:
2024-05-05 @ 9:42 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003210
Status:
COMPLETED
Last Update Posted:
2015-04-15
First Post:
1999-11-01
Brief Title:
Interleukin-12 in Treating Patients With Previously Treated Non-Hodgkins Lymphoma or Hodgkins Disease
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase II Study of Recombinant Human Interleukin-12 rhIL-12 for the Treatment of Relapsed Lymphoma and Hodgkins Disease
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 interleukin-12 in treating patients with previously treated non-Hodgkins lymphoma or Hodgkins disease Interleukin-12 may kill tumor cells by stopping blood flow to the tumor and by stimulating a persons white blood cells to kill lymphoma cells
Detailed Description:
PRIMARY OBJECTIVES
I Determine the response rate of interleukin-12 in previously treated patients with non-Hodgkins lymphoma or Hodgkins disease
II To determine the in vivo regulatory effect of interleukin-12 on Fas lingand FasL expression on patients peripheral blood lymphocytes
OUTLINE Patients are stratified according to disease characteristics low grade non-Hodgkins lymphoma follicular small cleaved follicular mixed small lymphocytic and variants versus intermediate grade non-Hodgkins lymphoma follicular large diffuse large diffuse mixed immunoblastic peripheral T-cell and mantle cell versus Hodgkins disease
Patients receive interleukin-12 subcutaneously twice a week Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity
PROJECTED ACCRUAL A total of 36-105 patients will be accrued for this study
I Determine the response rate of interleukin-12 in previously treated patients with non-Hodgkins lymphoma or Hodgkins disease
II To determine the in vivo regulatory effect of interleukin-12 on Fas lingand FasL expression on patients peripheral blood lymphocytes
OUTLINE Patients are stratified according to disease characteristics low grade non-Hodgkins lymphoma follicular small cleaved follicular mixed small lymphocytic and variants versus intermediate grade non-Hodgkins lymphoma follicular large diffuse large diffuse mixed immunoblastic peripheral T-cell and mantle cell versus Hodgkins disease
Patients receive interleukin-12 subcutaneously twice a week Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity
PROJECTED ACCRUAL A total of 36-105 patients will be accrued for this study
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 |
|---|---|---|---|
| NCI-2012-02264 | REGISTRY | None | None |
| CDR0000066067 | None | None | None |
| NCI-T97-0050 | None | None | None |
| DM-97073 | OTHER | None | None |
| T97-0050 | OTHER | None | None |
| N01CM17003 | NIH | CTEP | httpsreporternihgovquickSearchN01CM17003 |