Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00003750
Status:
COMPLETED
Last Update Posted:
2014-08-08
First Post:
1999-11-01
Brief Title:
Biological Therapy in Treating Children With Refractory or Recurrent Neuroblastoma or Other Tumors
Sponsor:
Childrens Oncology Group
Organization:
Childrens Oncology Group
Study Overview
Official Title:
A Phase IIB Intergroup Trial of the HU1418-IL2 Fusion Protein in Children With Refractory Neuroblastoma and Other GD2 Positive Tumors
Status:
COMPLETED
Status Verified Date:
2014-08
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 Biological therapies such as hu1418-interleukin-2 fusion protein use different ways to stimulate the immune system and stop cancer cells from growing
PURPOSE Phase I trial to study the effectiveness of hu1418-interleukin-2 fusion protein in treating children who have refractory or recurrent neuroblastoma or other tumors
PURPOSE Phase I trial to study the effectiveness of hu1418-interleukin-2 fusion protein in treating children who have refractory or recurrent neuroblastoma or other tumors
Detailed Description:
OBJECTIVES
Determine the maximum tolerated dose of hu1418-interleukin-2 fusion protein in children with refractory or recurrent neuroblastoma or other GD2-positive tumors
Determine the toxicity and pharmacokinetics of the fusion protein in these patients
Determine the effect of the fusion protein on systemic immune modulation in these patients
Quantitate the antifusion protein antibodies in patients treated with fusion protein
Evaluate antitumor responses resulting from this fusion protein regimen in these patients
OUTLINE This is a dose-escalation study
Patients receive hu1418-interleukin-2 hu1418-IL2 fusion protein IV over 4 hours once daily on days 1-3 Treatment repeats every 28 days for up to 4 courses in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of hu1418-IL2 fusion protein until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity
Patients are followed every 2 months for 1 year every 6 months for 3 years and then annually for 5 years
PROJECTED ACCRUAL A total of 18-24 patients will be accrued for this study within 1 year
Determine the maximum tolerated dose of hu1418-interleukin-2 fusion protein in children with refractory or recurrent neuroblastoma or other GD2-positive tumors
Determine the toxicity and pharmacokinetics of the fusion protein in these patients
Determine the effect of the fusion protein on systemic immune modulation in these patients
Quantitate the antifusion protein antibodies in patients treated with fusion protein
Evaluate antitumor responses resulting from this fusion protein regimen in these patients
OUTLINE This is a dose-escalation study
Patients receive hu1418-interleukin-2 hu1418-IL2 fusion protein IV over 4 hours once daily on days 1-3 Treatment repeats every 28 days for up to 4 courses in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of hu1418-IL2 fusion protein until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity
Patients are followed every 2 months for 1 year every 6 months for 3 years and then annually for 5 years
PROJECTED ACCRUAL A total of 18-24 patients will be accrued for this study within 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 |
|---|---|---|---|
| CDR0000066870 | OTHER | Clinical Trialsgov | None |
| COG-ADVL0018 | OTHER | None | None |