Ignite Creation Date:
2024-05-05 @ 11:28 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00052377
Status:
TERMINATED
Last Update Posted:
2013-01-16
First Post:
2003-01-24
Brief Title:
Interleukin-12 and Interleukin-2 in Treating Patients With Mycosis Fungoides
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase II Open-Label Study Of Recombinant Human Interleukin-12 NSC 672423 In Mycosis Fungoides MF Patients With Cross-Over To Phase I Evaluation Of Escalating Doses Of Interleukin-2 NSC 373364 Administered With Interleukin-12
Status:
TERMINATED
Status Verified Date:
2013-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Administratively complete
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Phase III trial to study the effectiveness of combining interleukin-12 with interleukin-2 in treating patients who have mycosis fungoides Biological therapies such as interleukin-12 and interleukin-2 use different ways to stimulate the immune system and stop cancer cells from growing Combining more than one biological therapy may kill more tumor cells
Detailed Description:
OBJECTIVES
I Determine the response rate complete and partial in patients with mycosis fungoides treated with interleukin-12 IL-12
II Determine the frequency of refractory disease in patients treated with this drug
III Determine the toxic effects of this drug in these patients IV Determine the feasibility and dose-limiting toxic effects DLT of interleukin-2 IL-2 when administered with IL-12 in patients who have not shown disease progression after 12 weeks of IL-12 and in those who have shown disease progression after 12 weeks of IL-12
V Determine the maximum tolerated dose and recommended dose of IL-2 when administered with IL-12 in these patients
VI Determine immune and cytokine response over time in patients treated with this regimen
VII Determine the frequency of improved clinical response in patients treated with this regimen
VIII Determine the biologic correlates of response including levels of interferon gamma production natural killer cell activity infiltration of skin lesions by CD8-positive cells lymphocyte IL-12 receptor expression signal transducers and activators of transcription protein levels and IL-12 signal transduction and induction of apoptosis in tumor cells in the skin of patients treated with this regimen
OUTLINE This is an open-label multicenter dose-escalation study of interleukin-2 IL-2
Patients receive interleukin-12 IL-12 subcutaneously SC twice weekly for 24 weeks
Disease is assessed at 13 weeks Patients who do not have progressive disease also receive IL-2 SC 3 consecutive days a week during weeks 13-24 Patients with progressive disease at week 13 receive IL-2 SC at a fixed dose during weeks 13-24
Patients with responding disease after week 24 may continue to receive IL-2 and IL-12 for another 12 weeks
Cohorts of 3-6 patients receive escalating doses of IL-2 until the maximum tolerated dose MTD is determined The MTD is defined as the dose at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity The recommended dose RD is the dose preceding the MTD Additional patients are treated at the RD
Patients are followed at 6 months
PROJECTED ACCRUAL A total of 18-46 patients will be accrued for this study within 28 months
I Determine the response rate complete and partial in patients with mycosis fungoides treated with interleukin-12 IL-12
II Determine the frequency of refractory disease in patients treated with this drug
III Determine the toxic effects of this drug in these patients IV Determine the feasibility and dose-limiting toxic effects DLT of interleukin-2 IL-2 when administered with IL-12 in patients who have not shown disease progression after 12 weeks of IL-12 and in those who have shown disease progression after 12 weeks of IL-12
V Determine the maximum tolerated dose and recommended dose of IL-2 when administered with IL-12 in these patients
VI Determine immune and cytokine response over time in patients treated with this regimen
VII Determine the frequency of improved clinical response in patients treated with this regimen
VIII Determine the biologic correlates of response including levels of interferon gamma production natural killer cell activity infiltration of skin lesions by CD8-positive cells lymphocyte IL-12 receptor expression signal transducers and activators of transcription protein levels and IL-12 signal transduction and induction of apoptosis in tumor cells in the skin of patients treated with this regimen
OUTLINE This is an open-label multicenter dose-escalation study of interleukin-2 IL-2
Patients receive interleukin-12 IL-12 subcutaneously SC twice weekly for 24 weeks
Disease is assessed at 13 weeks Patients who do not have progressive disease also receive IL-2 SC 3 consecutive days a week during weeks 13-24 Patients with progressive disease at week 13 receive IL-2 SC at a fixed dose during weeks 13-24
Patients with responding disease after week 24 may continue to receive IL-2 and IL-12 for another 12 weeks
Cohorts of 3-6 patients receive escalating doses of IL-2 until the maximum tolerated dose MTD is determined The MTD is defined as the dose at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity The recommended dose RD is the dose preceding the MTD Additional patients are treated at the RD
Patients are followed at 6 months
PROJECTED ACCRUAL A total of 18-46 patients will be accrued for this study within 28 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 |
|---|---|---|---|
| CDR0000258239 | REGISTRY | PDQ Physician Data Query | httpsreporternihgovquickSearchR01CA089442 |
| 10401 | None | None | None |
| R01CA089442 | NIH | None | None |