Ignite Creation Date:
2024-05-05 @ 10:05 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00008021
Status:
UNKNOWN
Last Update Posted:
2013-08-07
First Post:
2001-01-06
Brief Title:
Monoclonal Antibody Therapy Chemotherapy and Peripheral Stem Cell Transplantation in Treating Patients With Refractory Non-Hodgkins Lymphoma
Sponsor:
University of California Davis
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase I Study of 90Y-DOTA-Peptide-Lym-1 With Peripheral Blood Stem Cell Support Paclitaxel And Cyclosporin A In Patients With Non-Hodgkins Lymphoma
Status:
UNKNOWN
Status Verified Date:
2002-12
Last Known Status:
ACTIVE_NOT_RECRUITING
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 Monoclonal antibodies can locate cancer cells and either kill them or deliver tumor-killing substances to them without harming normal cells Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die Peripheral stem cell transplantation may allow doctors to give higher doses of chemotherapy and kill more cancer cells
PURPOSE Phase I trial to study the effectiveness of monoclonal antibody therapy cyclosporine and paclitaxel followed by peripheral stem cell transplantation in treating patients who have refractory non-Hodgkins lymphoma
PURPOSE Phase I trial to study the effectiveness of monoclonal antibody therapy cyclosporine and paclitaxel followed by peripheral stem cell transplantation in treating patients who have refractory non-Hodgkins lymphoma
Detailed Description:
OBJECTIVES
Determine the maximum tolerated dose of yttrium Y 90 monoclonal antibody Lym-1 administered with cyclosporine and paclitaxel followed by autologous peripheral blood stem cell transplantation in patients with refractory non-Hodgkins lymphoma
Determine the toxicity of this treatment regimen in these patients
OUTLINE This is an open-label dose escalation study of yttrium Y 90 monoclonal antibody Lym-1 Y90 MOAB Lym-1 Patients are assigned to one of four cohorts
Cohort I Patients receive filgrastim G-CSF subcutaneously SC beginning 4 days prior to peripheral blood stem cell PBSC mobilization and continuing until adequate PBSC are collected Patients receive unlabeled monoclonal antibody MOAB Lym-1 IV followed by a tracer dose of indium In 111 MOAB Lym-1 In111 MOAB Lym-1 IV on day 0 and unlabeled MOAB Lym-1 IV followed by Y90 MOAB Lym-1 IV on day 7 Patients also receive oral cyclosporine every 12 hours on days -2 to 14 Patients may undergo autologous PBSC transplantation if necessary no earlier than day 17 and receive G-CSF SC beginning at the completion of PBSC re-infusion and continuing until blood counts recover
Cohort II Patients undergo PBSC mobilization and receive treatment as in cohort I Patients also receive paclitaxel IV over 3 hours on day 9
Cohort III Patients undergo PBSC mobilization and receive unlabeled MOAB Lym-1 In111 MOAB Lym-1 Y90 MOAB Lym-1 and cyclosporine as in cohort I and paclitaxel as in cohort II Patients undergo autologous PBSC transplantation no earlier than day 17 Patients receive G-CSF after transplantation as in cohort I
Cohort IV Patients undergo PBSC mobilization and receive treatment as in cohort III Treatment repeats every 6 weeks for 2 courses in the absence of disease progression or unacceptable toxicity
Cohorts of 1 to 3 patients receive escalating doses of Y90 MOAB Lym-1 until the maximum tolerated dose MTD is determined The MTD is defined as the dose at which 1 of 3 patients require PBSC transplantation or the dose preceding that at which 2 of 3 patients experience dose-limiting toxicity
Patients are followed monthly for 3 months every 3 months for 1 year every 6 months for 1 year and then annually thereafter
PROJECTED ACCRUAL A maximum of 40 patients will be accrued for this study within 36 months
Determine the maximum tolerated dose of yttrium Y 90 monoclonal antibody Lym-1 administered with cyclosporine and paclitaxel followed by autologous peripheral blood stem cell transplantation in patients with refractory non-Hodgkins lymphoma
Determine the toxicity of this treatment regimen in these patients
OUTLINE This is an open-label dose escalation study of yttrium Y 90 monoclonal antibody Lym-1 Y90 MOAB Lym-1 Patients are assigned to one of four cohorts
Cohort I Patients receive filgrastim G-CSF subcutaneously SC beginning 4 days prior to peripheral blood stem cell PBSC mobilization and continuing until adequate PBSC are collected Patients receive unlabeled monoclonal antibody MOAB Lym-1 IV followed by a tracer dose of indium In 111 MOAB Lym-1 In111 MOAB Lym-1 IV on day 0 and unlabeled MOAB Lym-1 IV followed by Y90 MOAB Lym-1 IV on day 7 Patients also receive oral cyclosporine every 12 hours on days -2 to 14 Patients may undergo autologous PBSC transplantation if necessary no earlier than day 17 and receive G-CSF SC beginning at the completion of PBSC re-infusion and continuing until blood counts recover
Cohort II Patients undergo PBSC mobilization and receive treatment as in cohort I Patients also receive paclitaxel IV over 3 hours on day 9
Cohort III Patients undergo PBSC mobilization and receive unlabeled MOAB Lym-1 In111 MOAB Lym-1 Y90 MOAB Lym-1 and cyclosporine as in cohort I and paclitaxel as in cohort II Patients undergo autologous PBSC transplantation no earlier than day 17 Patients receive G-CSF after transplantation as in cohort I
Cohort IV Patients undergo PBSC mobilization and receive treatment as in cohort III Treatment repeats every 6 weeks for 2 courses in the absence of disease progression or unacceptable toxicity
Cohorts of 1 to 3 patients receive escalating doses of Y90 MOAB Lym-1 until the maximum tolerated dose MTD is determined The MTD is defined as the dose at which 1 of 3 patients require PBSC transplantation or the dose preceding that at which 2 of 3 patients experience dose-limiting toxicity
Patients are followed monthly for 3 months every 3 months for 1 year every 6 months for 1 year and then annually thereafter
PROJECTED ACCRUAL A maximum of 40 patients will be accrued for this study within 36 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 |
|---|---|---|---|
| NCI-V00-1638 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000068363 | REGISTRY | None | None |