Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00036855
Status:
TERMINATED
Last Update Posted:
2013-01-17
First Post:
2002-05-13
Brief Title:
Radiolabeled Monoclonal Antibody With or Without Peripheral Stem Cell Transplantation in Treating Children With Recurrent or Refractory Lymphoma
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase I Study Of Yttrium-Ibritumomab Tiuxetan 90Y Zevalin Yttrium 90-Anti-CD20 NSC 710085 Preceded By Rituximab In Children With RecurrentRefractory CD20 Positive Lymphoma
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 I trial to study the effectiveness of radiolabeled monoclonal antibody therapy with or without peripheral stem cell transplantation in treating patients who have recurrent or refractory lymphoma Radiolabeled monoclonal antibodies can locate cancer cells and deliver radioactive tumor-killing substances to them without harming normal cells Peripheral stem cell transplantation may be able to replace immune cells that were destroyed by anticancer therapy
Detailed Description:
OBJECTIVES
I Determine the maximum tolerated dose MTD of yttrium Y 90 ibritumomab tiuxetan IDEC-Y2B8 when preceded by rituximab in children with recurrent or refractory CD20-positive lymphoma for which no autologous peripheral blood stem cell transplantation AuPBSCT is planned Group A If the dose-limiting toxicity DLT in group A is purely hematological determine the MTD of IDEC-Y2B8 when combined with rituximab AuPBSCT and filgrastim G-CSF in a second group of children with recurrent or refractory CD20-positive lymphoma Group B II Determine the DLT of rituximab and IDEC-Y2B8 in these patients III Determine the dosimetry of indium In 111 ibritumomab tiuxetan preceded by rituximab in these patients
IV Determine preliminarily the antitumor activity of rituximab and IDEC-Y2B8 in these patients
V Assess the immune cell depletion B-cell and T-cell and recovery in patients treated with this regimen
VI Determine the human anti-mouse antibody response in patients treated with this regimen
OUTLINE This is a multicenter dose-escalation study of yttrium Y 90 ibritumomab tiuxetan IDEC-Y2B8 Patients are assigned to 1 of 2 groups
GROUP A no planned peripheral blood stem cell PBSC support Patients receive rituximab IV over 4-6 hours followed by indium In 111 ibritumomab tiuxetan IDEC-In2B8 IV over 10 minutes on day 0 and undergo whole body imaging Patients may then receive rituximab IV over 4-6 hours followed by IDEC-Y2B8 IV over 10 minutes on day 7
Cohorts of 3-6 patients in each subgroup A1 A2 and A3 receive escalating doses of IDEC-Y2B8 until the maximum tolerated dose MTD is determined subgroup A1 closed as of 10804 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 DLT
Some patients receive autologous PBSC IV over 30-60 minutes on day 35
GROUP B planned PBSC support Patients receive rituximab IDEC-In2B8 and IDEC-Y2B8 as in group A Patients also receive autologous PBSC IV over 30-60 minutes on day 21 and filgrastim G-CSF subcutaneously beginning on day 22 and continuing until blood counts recover or day 35
If the DLT in group A is purely hematological cohorts of 3-6 patients in group B receive escalating doses of IDEC-Y2B8 until the MTD is determined The MTD is defined as in group A
Patients in both groups are followed at days 63 90 180 365 and then annually thereafter
I Determine the maximum tolerated dose MTD of yttrium Y 90 ibritumomab tiuxetan IDEC-Y2B8 when preceded by rituximab in children with recurrent or refractory CD20-positive lymphoma for which no autologous peripheral blood stem cell transplantation AuPBSCT is planned Group A If the dose-limiting toxicity DLT in group A is purely hematological determine the MTD of IDEC-Y2B8 when combined with rituximab AuPBSCT and filgrastim G-CSF in a second group of children with recurrent or refractory CD20-positive lymphoma Group B II Determine the DLT of rituximab and IDEC-Y2B8 in these patients III Determine the dosimetry of indium In 111 ibritumomab tiuxetan preceded by rituximab in these patients
IV Determine preliminarily the antitumor activity of rituximab and IDEC-Y2B8 in these patients
V Assess the immune cell depletion B-cell and T-cell and recovery in patients treated with this regimen
VI Determine the human anti-mouse antibody response in patients treated with this regimen
OUTLINE This is a multicenter dose-escalation study of yttrium Y 90 ibritumomab tiuxetan IDEC-Y2B8 Patients are assigned to 1 of 2 groups
GROUP A no planned peripheral blood stem cell PBSC support Patients receive rituximab IV over 4-6 hours followed by indium In 111 ibritumomab tiuxetan IDEC-In2B8 IV over 10 minutes on day 0 and undergo whole body imaging Patients may then receive rituximab IV over 4-6 hours followed by IDEC-Y2B8 IV over 10 minutes on day 7
Cohorts of 3-6 patients in each subgroup A1 A2 and A3 receive escalating doses of IDEC-Y2B8 until the maximum tolerated dose MTD is determined subgroup A1 closed as of 10804 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 DLT
Some patients receive autologous PBSC IV over 30-60 minutes on day 35
GROUP B planned PBSC support Patients receive rituximab IDEC-In2B8 and IDEC-Y2B8 as in group A Patients also receive autologous PBSC IV over 30-60 minutes on day 21 and filgrastim G-CSF subcutaneously beginning on day 22 and continuing until blood counts recover or day 35
If the DLT in group A is purely hematological cohorts of 3-6 patients in group B receive escalating doses of IDEC-Y2B8 until the MTD is determined The MTD is defined as in group A
Patients in both groups are followed at days 63 90 180 365 and then annually thereafter
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 |
|---|---|---|---|
| CDR0000069331 | REGISTRY | PDQ Physician Data Query | httpsreporternihgovquickSearchU01CA097452 |
| ADVL0013 | None | None | None |
| U01CA097452 | NIH | None | None |