Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00012298
Status:
TERMINATED
Last Update Posted:
2018-08-09
First Post:
2001-03-03
Brief Title:
Radiolabeled Monoclonal Antibody Plus Rituximab With and Without Filgrastim and Interleukin-11 in Treating Patients With Relapsed or Refractory Non-Hodgkins Lymphoma
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase III Study of Two Sequential Doses of IDEC-Y2B8 in Patients With Relapsed Low-Grade and Follicular Non-Hodgkins Lymphoma
Status:
TERMINATED
Status Verified Date:
2018-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Trial completed prematurely
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 radiolabeled monoclonal antibody therapy and rituximab with and without filgrastim and interleukin-11 in treating patients who have relapsed or refractory non-Hodgkins lymphoma Radiolabeled monoclonal antibodies can locate cancer cells and deliver cancer-killing substances to them without harming normal cells Biological therapies such as filgrastim and interleukin-11 use different ways to stimulate the immune system and stop cancer cells from growing
Detailed Description:
PRIMARY OBJECTIVES
I Determine the maximum tolerated dose MTD of yttrium Y 90 ibritumomab tiuxetan IDEC-90Y2B8 administered with rituximab with and without filgrastim G-CSF and interleukin-11 IL-11 in patients with relapsed low-grade or follicular CD20 non-Hodgkins lymphoma Phase I II Determine the toxicity of this regimen in these patients III Determine the response rate in patients treated with this regimen IV Compare tumor and normal organ dosimetry with positron emission tomography and computerized tomography scans subsequent tumor response and normal organ toxicity by utilizing indium In 111 ibritumomab tiuxetan radioimmunoconjugate scans before each IDEC-90Y2B8 dose in these patients Phase I V Determine the immune response to this regimen in terms of human anti-mouse and human anti-chimeric antibody formation in these patients Phase I VI Determine whether G-CSF and IL-11 can ameliorate the effect of the MTD of IDEC-90Y2B8 on bone marrow function in these patients Phase I VII Determine progression-free survival at 3 years Phase II
OUTLINE
PHASE I Patients receive rituximab IV on days 1 and 8 indium In 111 ibritumomab tiuxetan IV over 10 minutes on day 1 for radioimaging and IDEC-90Y2B8 IV over 10 minutes on day 8 Treatment repeats 24-36 weeks later for a total of 2 courses in the absence of disease progression or unacceptable toxicity Once the maximum tolerated dose MTD of IDEC-90Y2B8 is determined patients also receive filgrastim G-CSF subcutaneously SC daily beginning when absolute neutrophil count is less than 1500mm3 and continuing until blood counts recover Patients also receive interleukin-11 IL-11 SC beginning when platelet count is less than 75000mm3 and continuing until blood counts recover Patients undergo PBSC transplantation only if marrow recovery is inadequate
Cohorts of 3-6 patients receive escalating doses of IDEC-90Y2B8 until the MTD is determined The MTD is defined as the dose preceding that at which at least 2 of 6 patients experience dose-limiting toxicity Once the MTD is determined additional patients are accrued to determine the MTD of this radioimmunotherapy with the addition of the prophylactic cytokines G-CSF and IL-11
PHASE II Patients receive rituximab indium In 111 ibritumomab tiuxetan and IDEC-90Y2B8 IV as determined at the MTD in phase I Treatment repeats 24-36 weeks later for a total of 2 courses in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed every 3 months for 1 year every 4 months for 1 year every 6 months for 1 year and then annually for 2 years
I Determine the maximum tolerated dose MTD of yttrium Y 90 ibritumomab tiuxetan IDEC-90Y2B8 administered with rituximab with and without filgrastim G-CSF and interleukin-11 IL-11 in patients with relapsed low-grade or follicular CD20 non-Hodgkins lymphoma Phase I II Determine the toxicity of this regimen in these patients III Determine the response rate in patients treated with this regimen IV Compare tumor and normal organ dosimetry with positron emission tomography and computerized tomography scans subsequent tumor response and normal organ toxicity by utilizing indium In 111 ibritumomab tiuxetan radioimmunoconjugate scans before each IDEC-90Y2B8 dose in these patients Phase I V Determine the immune response to this regimen in terms of human anti-mouse and human anti-chimeric antibody formation in these patients Phase I VI Determine whether G-CSF and IL-11 can ameliorate the effect of the MTD of IDEC-90Y2B8 on bone marrow function in these patients Phase I VII Determine progression-free survival at 3 years Phase II
OUTLINE
PHASE I Patients receive rituximab IV on days 1 and 8 indium In 111 ibritumomab tiuxetan IV over 10 minutes on day 1 for radioimaging and IDEC-90Y2B8 IV over 10 minutes on day 8 Treatment repeats 24-36 weeks later for a total of 2 courses in the absence of disease progression or unacceptable toxicity Once the maximum tolerated dose MTD of IDEC-90Y2B8 is determined patients also receive filgrastim G-CSF subcutaneously SC daily beginning when absolute neutrophil count is less than 1500mm3 and continuing until blood counts recover Patients also receive interleukin-11 IL-11 SC beginning when platelet count is less than 75000mm3 and continuing until blood counts recover Patients undergo PBSC transplantation only if marrow recovery is inadequate
Cohorts of 3-6 patients receive escalating doses of IDEC-90Y2B8 until the MTD is determined The MTD is defined as the dose preceding that at which at least 2 of 6 patients experience dose-limiting toxicity Once the MTD is determined additional patients are accrued to determine the MTD of this radioimmunotherapy with the addition of the prophylactic cytokines G-CSF and IL-11
PHASE II Patients receive rituximab indium In 111 ibritumomab tiuxetan and IDEC-90Y2B8 IV as determined at the MTD in phase I Treatment repeats 24-36 weeks later for a total of 2 courses in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed every 3 months for 1 year every 4 months for 1 year every 6 months for 1 year and then annually for 2 years
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-2009-00008 | REGISTRY | None | None |
| CDR0000068503 | None | None | None |
| MC998C | OTHER | None | None |
| 312 | OTHER | CTEP | None |