Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00009776
Status:
UNKNOWN
Last Update Posted:
2013-09-20
First Post:
2001-02-02
Brief Title:
Monoclonal Antibody Therapy Paclitaxel and Cyclosporine in Treating Patients With Recurrent or Refractory Non-Hodgkins Lymphoma
Sponsor:
University of California Davis
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Combined Modality Radioimmunotherapy For Non-Hodgkins Lymphoma With Three Cycles Of 90Y-DOTA-peptide-Lym-1 Paclitaxel and Cyclosporin A
Status:
UNKNOWN
Status Verified Date:
2001-10
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 tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells Combining monoclonal antibody therapy with cyclosporine and paclitaxel may be an effective treatment for non-Hodgkins lymphoma
PURPOSE Phase I trial to study the effectiveness of radiolabeled monoclonal antibody therapy combined with paclitaxel and cyclosporine in treating patients who have recurrent or refractory non-Hodgkins lymphoma
PURPOSE Phase I trial to study the effectiveness of radiolabeled monoclonal antibody therapy combined with paclitaxel and cyclosporine in treating patients who have recurrent or refractory non-Hodgkins lymphoma
Detailed Description:
OBJECTIVES
Determine the maximum tolerated dose of yttrium Y 90 monoclonal antibody Lym-1 in combination with paclitaxel and cyclosporine in patients with recurrent or refractory non-Hodgkins lymphoma
OUTLINE This is a dose-escalation study of yttrium Y 90 monoclonal antibody Lym-1 Y90 MOAB Lym-1
Patients receive oral cyclosporine every 12 hours on days -2 to 14 Patients receive unlabeled MOAB Lym-1 IV followed by a tracer dose of indium In 111 MOAB Lym-1 IV on day 0 On day 7 patients receive unlabeled MOAB Lym-1 IV followed by Y90 MOAB Lym-1 IV Patients in cohorts 2-4 also receive paclitaxel IV over 3 hours on day 9 Courses repeat every 8 weeks for a total of 3 courses in the absence of disease progression or unacceptable toxicity
Cohorts of 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 preceding that at which 2 of 3 patients experience dose-limiting toxicity
Patients are followed monthly for 3 months every 3 months for 21 months and then every 6 months for 3 years
PROJECTED ACCRUAL A total of 24 patients will be accrued for this study within 36 months
Determine the maximum tolerated dose of yttrium Y 90 monoclonal antibody Lym-1 in combination with paclitaxel and cyclosporine in patients with recurrent or refractory non-Hodgkins lymphoma
OUTLINE This is a dose-escalation study of yttrium Y 90 monoclonal antibody Lym-1 Y90 MOAB Lym-1
Patients receive oral cyclosporine every 12 hours on days -2 to 14 Patients receive unlabeled MOAB Lym-1 IV followed by a tracer dose of indium In 111 MOAB Lym-1 IV on day 0 On day 7 patients receive unlabeled MOAB Lym-1 IV followed by Y90 MOAB Lym-1 IV Patients in cohorts 2-4 also receive paclitaxel IV over 3 hours on day 9 Courses repeat every 8 weeks for a total of 3 courses in the absence of disease progression or unacceptable toxicity
Cohorts of 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 preceding that at which 2 of 3 patients experience dose-limiting toxicity
Patients are followed monthly for 3 months every 3 months for 21 months and then every 6 months for 3 years
PROJECTED ACCRUAL A total of 24 patients will be accrued for this study within 36 months
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-V00-1641 | None | None | None |
| UCD-991869 | None | None | None |