Ignite Creation Date:
2024-05-05 @ 11:29 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00054405
Status:
TERMINATED
Last Update Posted:
2013-04-09
First Post:
2003-02-05
Brief Title:
Interleukin-12 and Interleukin-2 in Treating Patients With Refractory or Recurrent Neuroblastoma
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase I Investigation of IL-12 NSC 672423Pulse IL-2 Aldesleukin in Children With Persistent andor Refractory Neuroblastoma 13623
Status:
TERMINATED
Status Verified Date:
2013-04
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 I trial to compare the effectiveness of interleukin-12 with or without interleukin-2 in treating young patients who have refractory or recurrent neuroblastoma Biological therapies use different ways to stimulate the immune system and stop cancer cells from growing Combining interleukin-2 with interleukin-12 may kill more tumor cells
Detailed Description:
OBJECTIVES
I Define the maximum tolerated dose and dose-limiting toxicity of interleukin-12 with or without interleukin-2 in patients with refractory or recurrent neuroblastoma
II Determine preliminarily the antitumor effect of interleukin-12 with or without interleukin-2 in these patients
III Evaluate the immunoregulatory activity of interleukin-12 with or without interleukin-2 in these patients
IV Evaluate the antiangiogenic activity of interleukin-12 with or without interleukin-2 in these patients
OUTLINE This is a dose-escalation multicenter study Patients are assigned to 1 of 2 treatment cohorts
COHORT A Patients receive interleukin-12 IL-12 IV over 5-15 seconds on days 1 3 5 8 10 and 12
COHORT B Patients receive interleukin-2 IL-2 IV over 15 minutes twice daily on days 1 and 8 and IL-12 IV as in cohort A
Treatment in both cohorts repeats every 28 days for up to 4 courses in the absence of disease progression or unacceptable toxicity Some patients may receive additional courses at the discretion of the principal investigator
Cohorts of 3-6 patients in both cohorts receive escalating doses of IL-2 and IL-12 until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity
Once the MTD is determined an additional cohort of 8 patients receives IL-12 and IL-2 at the MTD
Patients are followed at 3 weeks
I Define the maximum tolerated dose and dose-limiting toxicity of interleukin-12 with or without interleukin-2 in patients with refractory or recurrent neuroblastoma
II Determine preliminarily the antitumor effect of interleukin-12 with or without interleukin-2 in these patients
III Evaluate the immunoregulatory activity of interleukin-12 with or without interleukin-2 in these patients
IV Evaluate the antiangiogenic activity of interleukin-12 with or without interleukin-2 in these patients
OUTLINE This is a dose-escalation multicenter study Patients are assigned to 1 of 2 treatment cohorts
COHORT A Patients receive interleukin-12 IL-12 IV over 5-15 seconds on days 1 3 5 8 10 and 12
COHORT B Patients receive interleukin-2 IL-2 IV over 15 minutes twice daily on days 1 and 8 and IL-12 IV as in cohort A
Treatment in both cohorts repeats every 28 days for up to 4 courses in the absence of disease progression or unacceptable toxicity Some patients may receive additional courses at the discretion of the principal investigator
Cohorts of 3-6 patients in both cohorts receive escalating doses of IL-2 and IL-12 until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity
Once the MTD is determined an additional cohort of 8 patients receives IL-12 and IL-2 at the MTD
Patients are followed at 3 weeks
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 |
|---|---|---|---|
| NANT 2001-01 | None | None | None |
| CDR0000270447 | None | None | None |
| P01CA081403 | NIH | None | None |
| CDR0000270447 | REGISTRY | PDQ Physician Data Query | httpsreporternihgovquickSearchP01CA081403 |